<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477694</url>
  </required_header>
  <id_info>
    <org_study_id>K19/320</org_study_id>
    <nct_id>NCT04477694</nct_id>
  </id_info>
  <brief_title>The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia</brief_title>
  <official_title>The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon&#xD;
      polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients&#xD;
      are recommended to have colonoscopy frequently. The aim of this study is to search the effect&#xD;
      of DM on hemodynamics, procedure times, anesthetic consumption and complications in&#xD;
      colonoscopy under sedoanalgesia.&#xD;
&#xD;
      MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of&#xD;
      Başkent University, this study is planned to be prospective and double-blind in 50 type II&#xD;
      diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for&#xD;
      elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of&#xD;
      18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy,&#xD;
      previous adverse reactions to medications used in the study, history of anesthesia and&#xD;
      sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or&#xD;
      sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced&#xD;
      stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic&#xD;
      sensorymotor and autonomic neuropathy.&#xD;
&#xD;
      After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2,&#xD;
      respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other&#xD;
      effects will be recorded.&#xD;
&#xD;
      EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that&#xD;
      diabetic patients have during colonoscopy and applying a special patient care protocol for&#xD;
      these patients is suggested to improve the procedure and outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 27, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied mean blood pressure will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied heart rate will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied SpO2 will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied respiratuar rate will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied Ramsay sedation score level will be recorded. Ramsay sedation score level will be 3 during the process. When the score level is 2, at the end of the procedure, it will be taken to the postoperative intensive care unite.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied modified post anaesthetic discharge score level will be recorded. Patients will be discharged when the score level is 9 or above.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied procedure times will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied total anaesthetic doses will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>After sedoanalgesia is applied stomach ache and other effects will be recorded. Stomach ache will be evaluated by visuel analog pain scale. When it is 4 or above, will be considered meaningful.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Sedoanalgesia</condition>
  <arm_group>
    <arm_group_label>type II diabetic patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-diabetic patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy under sedoanalgesia</intervention_name>
    <description>Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.</description>
    <arm_group_label>non-diabetic patients</arm_group_label>
    <arm_group_label>type II diabetic patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Type II diabetic and non-diabetic ASA I-II, aged between 18-65 years female patients&#xD;
        scheduled for elective colonoscopy under sedoanalgesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients aged between 18-65 years old&#xD;
&#xD;
          -  Type II diabetic and non-diabetic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age outside the range of 18-65 years&#xD;
&#xD;
          -  ASA phsical status ≥ 3&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous adverse reactions to medications used in the study&#xD;
&#xD;
          -  History of anesthesia and sedation in the last 7 days&#xD;
&#xD;
          -  Psychiatric or emotional disorders&#xD;
&#xD;
          -  Addiction to the opioids or sedatives used in the study&#xD;
&#xD;
          -  Diabetic nephrophathy, high BUN and creatinine values&#xD;
&#xD;
          -  Advanced stages of diabetic nonalcoholic liver disease and high liver function tests&#xD;
&#xD;
          -  Diabetic sensorymotor and autonomic neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yonca Özvardar Pekcan</last_name>
    <phone>+90 232 2411000</phone>
    <phone_ext>1085</phone_ext>
    <email>yncapek@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bahattin Tuncalı</last_name>
    <phone>+90 232 2411000</phone>
    <phone_ext>1260</phone_ext>
    <email>tuncali.bahattin@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Baskent University Zubeyde Hanim Practice and Research Center</name>
      <address>
        <city>İzmir</city>
        <state>Karşıyaka</state>
        <zip>35540</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Özvardar Pekcan</last_name>
      <phone>+90 232 2411000</phone>
      <phone_ext>1085</phone_ext>
      <email>yncapek@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Tuncalı</last_name>
      <phone>+90 232 2411000</phone>
      <phone_ext>1260</phone_ext>
      <email>tuncali.bahattin@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.</citation>
    <PMID>29496507</PMID>
  </reference>
  <reference>
    <citation>Zhao G, Ford ES, Ahluwalia IB, Li C, Mokdad AH. Prevalence and trends of receipt of cancer screenings among US women with diagnosed diabetes. J Gen Intern Med. 2009 Feb;24(2):270-5. doi: 10.1007/s11606-008-0858-8. Epub 2008 Dec 17.</citation>
    <PMID>19089511</PMID>
  </reference>
  <reference>
    <citation>Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus report. Diabetes Care. 2010 Jul;33(7):1674-85. doi: 10.2337/dc10-0666.</citation>
    <PMID>20587728</PMID>
  </reference>
  <reference>
    <citation>Noto H, Tsujimoto T, Sasazuki T, Noda M. Significantly increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis. Endocr Pract. 2011 Jul-Aug;17(4):616-28. doi: 10.4158/EP10357.RA.</citation>
    <PMID>21454235</PMID>
  </reference>
  <reference>
    <citation>Yang X, Ko GT, So WY, Ma RC, Yu LW, Kong AP, Zhao H, Chow CC, Tong PC, Chan JC. Associations of hyperglycemia and insulin usage with the risk of cancer in type 2 diabetes: the Hong Kong diabetes registry. Diabetes. 2010 May;59(5):1254-60. doi: 10.2337/db09-1371. Epub 2010 Feb 25.</citation>
    <PMID>20185812</PMID>
  </reference>
  <reference>
    <citation>Renehan AG, Zwahlen M, Minder C, O'Dwyer ST, Shalet SM, Egger M. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet. 2004 Apr 24;363(9418):1346-53. doi: 10.1016/S0140-6736(04)16044-3.</citation>
    <PMID>15110491</PMID>
  </reference>
  <reference>
    <citation>Diaz-Algorri Y, Lozada ME, Lopez SM, Bertran-Rodriguez CE, Gonzalez-Hernandez CM, Gonzalez D, Perez-Cardona CM, Hernandez J, Pedrosa C, Toro DH, Gonzalez-Pons M, Cruz-Correa M. Type 2 diabetes mellitus and colorectal neoplasia risk in Hispanics: a case-control study. J Diabetes Complications. 2015 May-Jun;29(4):502-7. doi: 10.1016/j.jdiacomp.2015.01.010. Epub 2015 Feb 3.</citation>
    <PMID>25784088</PMID>
  </reference>
  <reference>
    <citation>Vu HT, Ufere N, Yan Y, Wang JS, Early DS, Elwing JE. Diabetes mellitus increases risk for colorectal adenomas in younger patients. World J Gastroenterol. 2014 Jun 14;20(22):6946-52. doi: 10.3748/wjg.v20.i22.6946.</citation>
    <PMID>24944487</PMID>
  </reference>
  <reference>
    <citation>Kanadiya MK, Gohel TD, Sanaka MR, Thota PN, Shubrook JH Jr. Relationship between type-2 diabetes and use of metformin with risk of colorectal adenoma in an American population receiving colonoscopy. J Diabetes Complications. 2013 Sep-Oct;27(5):463-6. doi: 10.1016/j.jdiacomp.2013.04.010. Epub 2013 Jun 5.</citation>
    <PMID>23755906</PMID>
  </reference>
  <reference>
    <citation>Suh S, Kang M, Kim MY, Chung HS, Kim SK, Hur KY, Kim JH, Lee MS, Lee MK, Kim KW. Korean type 2 diabetes patients have multiple adenomatous polyps compared to non-diabetic controls. J Korean Med Sci. 2011 Sep;26(9):1196-200. doi: 10.3346/jkms.2011.26.9.1196. Epub 2011 Sep 1.</citation>
    <PMID>21935276</PMID>
  </reference>
  <reference>
    <citation>Giouleme O, Diamantidis MD, Katsaros MG. Is diabetes a causal agent for colorectal cancer? Pathophysiological and molecular mechanisms. World J Gastroenterol. 2011 Jan 28;17(4):444-8. doi: 10.3748/wjg.v17.i4.444.</citation>
    <PMID>21274373</PMID>
  </reference>
  <reference>
    <citation>Erbach M, Mehnert H, Schnell O. Diabetes and the risk for colorectal cancer. J Diabetes Complications. 2012 Jan-Feb;26(1):50-5. doi: 10.1016/j.jdiacomp.2011.11.003. Epub 2012 Feb 7.</citation>
    <PMID>22321219</PMID>
  </reference>
  <reference>
    <citation>Laish I, Mizrahi J, Naftali T, Konikoff FM. Diabetes Mellitus and Age are Risk Factors of Interval Colon Cancer: A Case-Control Study. Dig Dis. 2019;37(4):291-296. doi: 10.1159/000496740. Epub 2019 Feb 7.</citation>
    <PMID>30731459</PMID>
  </reference>
  <reference>
    <citation>Fanti L, Testoni PA. Sedation and analgesia in gastrointestinal endoscopy: what's new? World J Gastroenterol. 2010 May 28;16(20):2451-7. doi: 10.3748/wjg.v16.i20.2451.</citation>
    <PMID>20503443</PMID>
  </reference>
  <reference>
    <citation>Cornelius BW. Patients With Type 2 Diabetes: Anesthetic Management in the Ambulatory Setting. Part 1: Pathophysiology and Associated Disease States. Anesth Prog. 2016 Winter;63(4):208-215. doi: 10.2344/0003-3006-63.4.208.</citation>
    <PMID>27973934</PMID>
  </reference>
  <reference>
    <citation>Raz I, Hasdai D, Seltzer Z, Melmed RN. Effect of hyperglycemia on pain perception and on efficacy of morphine analgesia in rats. Diabetes. 1988 Sep;37(9):1253-9. doi: 10.2337/diab.37.9.1253.</citation>
    <PMID>3410166</PMID>
  </reference>
  <reference>
    <citation>Park SH, Bahk JH, Oh AY, Gil NS, Huh J, Lee JH. Gender difference and change of alpha(1)-adrenoceptors in the distal mesenteric arteries of streptozotocin-induced diabetic rats. Korean J Anesthesiol. 2011 Nov;61(5):419-27. doi: 10.4097/kjae.2011.61.5.419. Epub 2011 Nov 23.</citation>
    <PMID>22148092</PMID>
  </reference>
  <reference>
    <citation>Gul H, Yildiz O, Dogrul A, Yesilyurt O, Isimer A. The interaction between IL-1beta and morphine: possible mechanism of the deficiency of morphine-induced analgesia in diabetic mice. Pain. 2000 Dec 15;89(1):39-45. doi: 10.1016/S0304-3959(00)00343-2.</citation>
    <PMID>11113291</PMID>
  </reference>
  <reference>
    <citation>Karci A, Tasdogen A, Erkin Y, Aktas G, Elar Z. The analgesic effect of morphine on postoperative pain in diabetic patients. Acta Anaesthesiol Scand. 2004 May;48(5):619-24. doi: 10.1111/j.1399-6576.2004.00387.x.</citation>
    <PMID>15101859</PMID>
  </reference>
  <reference>
    <citation>deRoux SJ, Sgarlato A. Upper and lower gastrointestinal endoscopy mortality: the medical examiner's perspective. Forensic Sci Med Pathol. 2012 Mar;8(1):4-12. doi: 10.1007/s12024-011-9257-2. Epub 2011 Jun 11.</citation>
    <PMID>21667169</PMID>
  </reference>
  <reference>
    <citation>De Cosmo G, Congedo E, Lai C, Primieri P, Dottarelli A, Aceto P. Preoperative psychologic and demographic predictors of pain perception and tramadol consumption using intravenous patient-controlled analgesia. Clin J Pain. 2008 Jun;24(5):399-405. doi: 10.1097/AJP.0b013e3181671a08.</citation>
    <PMID>18496304</PMID>
  </reference>
  <reference>
    <citation>Uchiyama K, Kawai M, Tani M, Ueno M, Hama T, Yamaue H. Gender differences in postoperative pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Mar;20(3):448-51. doi: 10.1007/s00464-005-0406-0. Epub 2006 Jan 21.</citation>
    <PMID>16432649</PMID>
  </reference>
  <reference>
    <citation>Mogil JS. Sex differences in pain and pain inhibition: multiple explanations of a controversial phenomenon. Nat Rev Neurosci. 2012 Dec;13(12):859-66. doi: 10.1038/nrn3360.</citation>
    <PMID>23165262</PMID>
  </reference>
  <reference>
    <citation>Newcomer MK, Shaw MJ, Williams DM, Jowell PS. Unplanned work absence following outpatient colonoscopy. J Clin Gastroenterol. 1999 Jul;29(1):76-8. doi: 10.1097/00004836-199907000-00019.</citation>
    <PMID>10405238</PMID>
  </reference>
  <reference>
    <citation>Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy. Dis Colon Rectum. 2005 Jun;48(6):1295-300. doi: 10.1007/s10350-004-0940-1.</citation>
    <PMID>15793639</PMID>
  </reference>
  <reference>
    <citation>Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997 Jul;20(7):1183-97. doi: 10.2337/diacare.20.7.1183. No abstract available.</citation>
    <PMID>9203460</PMID>
  </reference>
  <reference>
    <citation>Hochberg I, Segol O, Shental R, Shimoni P, Eldor R. Antihyperglycemic therapy during colonoscopy preparation: A review and suggestions for practical recommendations. United European Gastroenterol J. 2019 Jul;7(6):735-740. doi: 10.1177/2050640619846365. Epub 2019 Apr 20.</citation>
    <PMID>31316777</PMID>
  </reference>
  <reference>
    <citation>Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.</citation>
    <PMID>4835444</PMID>
  </reference>
  <reference>
    <citation>Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.</citation>
    <PMID>8534468</PMID>
  </reference>
  <reference>
    <citation>Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.</citation>
    <PMID>25801162</PMID>
  </reference>
  <reference>
    <citation>31. Kayhan Z: Ağrının ölçülmesi: Klinik Anestezi 2019; Logos yayıncılık</citation>
  </reference>
  <reference>
    <citation>32. Satman İ, Alagöl F, Ömer B, Kalaca S, Tütüncü Y, Çolak N. Türkiye Diyabet, Hipertansiyon, Obezite ve Endokrinolojik Hastalıklar Prevalans Çalışması-II. (TURDEP II) 2011.</citation>
  </reference>
  <reference>
    <citation>Joshi GP, Chung F, Vann MA, Ahmad S, Gan TJ, Goulson DT, Merrill DG, Twersky R; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010 Dec;111(6):1378-87. doi: 10.1213/ANE.0b013e3181f9c288. Epub 2010 Oct 1.</citation>
    <PMID>20889933</PMID>
  </reference>
  <reference>
    <citation>Cornelius BW. Patients With Type 2 Diabetes: Anesthetic Management in the Ambulatory Setting: Part 2: Pharmacology and Guidelines for Perioperative Management. Anesth Prog. 2017 Spring;64(1):39-44. doi: 10.2344/anpr-64-01-02.</citation>
    <PMID>28128657</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Yonca Özvardar Pekcan</investigator_full_name>
    <investigator_title>MD, Anesthesia and Reanimation specialist, principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Sedoanalgesia</keyword>
  <keyword>Colonoscopy under sedoanalgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477694
org study id: K19/320
nct id: NCT04477694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon
      polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients
      are recommended to have colonoscopy frequently. The aim of this study is to search the effect
      of DM on hemodynamics, procedure times, anesthetic consumption and complications in
      colonoscopy under sedoanalgesia.

      MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of
      Başkent University, this study is planned to be prospective and double-blind in 50 type II
      diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for
      elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of
      18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy,
      previous adverse reactions to medications used in the study, history of anesthesia and
      sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or
      sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced
      stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic
      sensorymotor and autonomic neuropathy.

      After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2,
      respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other
      effects will be recorded.

      EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that
      diabetic patients have during colonoscopy and applying a special patient care protocol for
      these patients is suggested to improve the procedure and outcomes.
observational model: Cohort
time perspective: Prospective
measure: Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied mean blood pressure will be recorded.
measure: Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied heart rate will be recorded.
measure: Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied SpO2 will be recorded.
measure: Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied respiratuar rate will be recorded.
measure: Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied Ramsay sedation score level will be recorded. Ramsay sedation score level will be 3 during the process. When the score level is 2, at the end of the procedure, it will be taken to the postoperative intensive care unite.
measure: Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied modified post anaesthetic discharge score level will be recorded. Patients will be discharged when the score level is 9 or above.
measure: Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied procedure times will be recorded.
measure: Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied total anaesthetic doses will be recorded.
measure: Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
time frame: 24 hour
description: After sedoanalgesia is applied stomach ache and other effects will be recorded. Stomach ache will be evaluated by visuel analog pain scale. When it is 4 or above, will be considered meaningful.
arm group label: type II diabetic patients
arm group label: non-diabetic patients
intervention type: Procedure
intervention name: colonoscopy under sedoanalgesia
description: Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
arm group label: non-diabetic patients
arm group label: type II diabetic patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yonca Özvardar Pekcan
phone: +90 232 2411000
phone ext: 1085
email: yncapek@gmail.com
last name: Bahattin Tuncalı
phone: +90 232 2411000
phone ext: 1260
email: tuncali.bahattin@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PMID: 29496507
citation: Zhao G, Ford ES, Ahluwalia IB, Li C, Mokdad AH. Prevalence and trends of receipt of cancer screenings among US women with diagnosed diabetes. J Gen Intern Med. 2009 Feb;24(2):270-5. doi: 10.1007/s11606-008-0858-8. Epub 2008 Dec 17.
PMID: 19089511
citation: Giovannucci E, Harlan DM, Archer MC, Bergenstal RM, Gapstur SM, Habel LA, Pollak M, Regensteiner JG, Yee D. Diabetes and cancer: a consensus report. Diabetes Care. 2010 Jul;33(7):1674-85. doi: 10.2337/dc10-0666.
PMID: 20587728
citation: Noto H, Tsujimoto T, Sasazuki T, Noda M. Significantly increased risk of cancer in patients with diabetes mellitus: a systematic review and meta-analysis. Endocr Pract. 2011 Jul-Aug;17(4):616-28. doi: 10.4158/EP10357.RA.
PMID: 21454235
citation: Yang X, Ko GT, So WY, Ma RC, Yu LW, Kong AP, Zhao H, Chow CC, Tong PC, Chan JC. Associations of hyperglycemia and insulin usage with the risk of cancer in type 2 diabetes: the Hong Kong diabetes registry. Diabetes. 2010 May;59(5):1254-60. doi: 10.2337/db09-1371. Epub 2010 Feb 25.
PMID: 20185812
citation: Renehan AG, Zwahlen M, Minder C, O'Dwyer ST, Shalet SM, Egger M. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet. 2004 Apr 24;363(9418):1346-53. doi: 10.1016/S0140-6736(04)16044-3.
PMID: 15110491
citation: Diaz-Algorri Y, Lozada ME, Lopez SM, Bertran-Rodriguez CE, Gonzalez-Hernandez CM, Gonzalez D, Perez-Cardona CM, Hernandez J, Pedrosa C, Toro DH, Gonzalez-Pons M, Cruz-Correa M. Type 2 diabetes mellitus and colorectal neoplasia risk in Hispanics: a case-control study. J Diabetes Complications. 2015 May-Jun;29(4):502-7. doi: 10.1016/j.jdiacomp.2015.01.010. Epub 2015 Feb 3.
PMID: 25784088
citation: Vu HT, Ufere N, Yan Y, Wang JS, Early DS, Elwing JE. Diabetes mellitus increases risk for colorectal adenomas in younger patients. World J Gastroenterol. 2014 Jun 14;20(22):6946-52. doi: 10.3748/wjg.v20.i22.6946.
PMID: 24944487
citation: Kanadiya MK, Gohel TD, Sanaka MR, Thota PN, Shubrook JH Jr. Relationship between type-2 diabetes and use of metformin with risk of colorectal adenoma in an American population receiving colonoscopy. J Diabetes Complications. 2013 Sep-Oct;27(5):463-6. doi: 10.1016/j.jdiacomp.2013.04.010. Epub 2013 Jun 5.
PMID: 23755906
citation: Suh S, Kang M, Kim MY, Chung HS, Kim SK, Hur KY, Kim JH, Lee MS, Lee MK, Kim KW. Korean type 2 diabetes patients have multiple adenomatous polyps compared to non-diabetic controls. J Korean Med Sci. 2011 Sep;26(9):1196-200. doi: 10.3346/jkms.2011.26.9.1196. Epub 2011 Sep 1.
PMID: 21935276
citation: Giouleme O, Diamantidis MD, Katsaros MG. Is diabetes a causal agent for colorectal cancer? Pathophysiological and molecular mechanisms. World J Gastroenterol. 2011 Jan 28;17(4):444-8. doi: 10.3748/wjg.v17.i4.444.
PMID: 21274373
citation: Erbach M, Mehnert H, Schnell O. Diabetes and the risk for colorectal cancer. J Diabetes Complications. 2012 Jan-Feb;26(1):50-5. doi: 10.1016/j.jdiacomp.2011.11.003. Epub 2012 Feb 7.
PMID: 22321219
citation: Laish I, Mizrahi J, Naftali T, Konikoff FM. Diabetes Mellitus and Age are Risk Factors of Interval Colon Cancer: A Case-Control Study. Dig Dis. 2019;37(4):291-296. doi: 10.1159/000496740. Epub 2019 Feb 7.
PMID: 30731459
citation: Fanti L, Testoni PA. Sedation and analgesia in gastrointestinal endoscopy: what's new? World J Gastroenterol. 2010 May 28;16(20):2451-7. doi: 10.3748/wjg.v16.i20.2451.
PMID: 20503443
citation: Cornelius BW. Patients With Type 2 Diabetes: Anesthetic Management in the Ambulatory Setting. Part 1: Pathophysiology and Associated Disease States. Anesth Prog. 2016 Winter;63(4):208-215. doi: 10.2344/0003-3006-63.4.208.
PMID: 27973934
citation: Raz I, Hasdai D, Seltzer Z, Melmed RN. Effect of hyperglycemia on pain perception and on efficacy of morphine analgesia in rats. Diabetes. 1988 Sep;37(9):1253-9. doi: 10.2337/diab.37.9.1253.
PMID: 3410166
citation: Park SH, Bahk JH, Oh AY, Gil NS, Huh J, Lee JH. Gender difference and change of alpha(1)-adrenoceptors in the distal mesenteric arteries of streptozotocin-induced diabetic rats. Korean J Anesthesiol. 2011 Nov;61(5):419-27. doi: 10.4097/kjae.2011.61.5.419. Epub 2011 Nov 23.
PMID: 22148092
citation: Gul H, Yildiz O, Dogrul A, Yesilyurt O, Isimer A. The interaction between IL-1beta and morphine: possible mechanism of the deficiency of morphine-induced analgesia in diabetic mice. Pain. 2000 Dec 15;89(1):39-45. doi: 10.1016/S0304-3959(00)00343-2.
PMID: 11113291
citation: Karci A, Tasdogen A, Erkin Y, Aktas G, Elar Z. The analgesic effect of morphine on postoperative pain in diabetic patients. Acta Anaesthesiol Scand. 2004 May;48(5):619-24. doi: 10.1111/j.1399-6576.2004.00387.x.
PMID: 15101859
citation: deRoux SJ, Sgarlato A. Upper and lower gastrointestinal endoscopy mortality: the medical examiner's perspective. Forensic Sci Med Pathol. 2012 Mar;8(1):4-12. doi: 10.1007/s12024-011-9257-2. Epub 2011 Jun 11.
PMID: 21667169
citation: De Cosmo G, Congedo E, Lai C, Primieri P, Dottarelli A, Aceto P. Preoperative psychologic and demographic predictors of pain perception and tramadol consumption using intravenous patient-controlled analgesia. Clin J Pain. 2008 Jun;24(5):399-405. doi: 10.1097/AJP.0b013e3181671a08.
PMID: 18496304
citation: Uchiyama K, Kawai M, Tani M, Ueno M, Hama T, Yamaue H. Gender differences in postoperative pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Mar;20(3):448-51. doi: 10.1007/s00464-005-0406-0. Epub 2006 Jan 21.
PMID: 16432649
citation: Mogil JS. Sex differences in pain and pain inhibition: multiple explanations of a controversial phenomenon. Nat Rev Neurosci. 2012 Dec;13(12):859-66. doi: 10.1038/nrn3360.
PMID: 23165262
citation: Newcomer MK, Shaw MJ, Williams DM, Jowell PS. Unplanned work absence following outpatient colonoscopy. J Clin Gastroenterol. 1999 Jul;29(1):76-8. doi: 10.1097/00004836-199907000-00019.
PMID: 10405238
citation: Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy. Dis Colon Rectum. 2005 Jun;48(6):1295-300. doi: 10.1007/s10350-004-0940-1.
PMID: 15793639
citation: Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997 Jul;20(7):1183-97. doi: 10.2337/diacare.20.7.1183. No abstract available.
PMID: 9203460
citation: Hochberg I, Segol O, Shental R, Shimoni P, Eldor R. Antihyperglycemic therapy during colonoscopy preparation: A review and suggestions for practical recommendations. United European Gastroenterol J. 2019 Jul;7(6):735-740. doi: 10.1177/2050640619846365. Epub 2019 Apr 20.
PMID: 31316777
citation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PMID: 4835444
citation: Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.
PMID: 8534468
citation: Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.
PMID: 25801162
citation: 31. Kayhan Z: Ağrının ölçülmesi: Klinik Anestezi 2019; Logos yayıncılık
citation: 32. Satman İ, Alagöl F, Ömer B, Kalaca S, Tütüncü Y, Çolak N. Türkiye Diyabet, Hipertansiyon, Obezite ve Endokrinolojik Hastalıklar Prevalans Çalışması-II. (TURDEP II) 2011.
citation: Joshi GP, Chung F, Vann MA, Ahmad S, Gan TJ, Goulson DT, Merrill DG, Twersky R; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010 Dec;111(6):1378-87. doi: 10.1213/ANE.0b013e3181f9c288. Epub 2010 Oct 1.
PMID: 20889933
citation: Cornelius BW. Patients With Type 2 Diabetes: Anesthetic Management in the Ambulatory Setting: Part 2: Pharmacology and Guidelines for Perioperative Management. Anesth Prog. 2017 Spring;64(1):39-44. doi: 10.2344/anpr-64-01-02.
PMID: 28128657
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Yonca Özvardar Pekcan
investigator title: MD, Anesthesia and Reanimation specialist, principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No