<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/NCT03813303</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE56538616230015121</org_study_id>
    <nct_id>NCT03813303</nct_id>
  </id_info>
  <brief_title>Comparison of Post Anesthetic Recovery Time in Sedated Patients for Colonoscopy</brief_title>
  <acronym>CPART</acronym>
  <official_title>Comparison of Post Anesthetic Recovery Time in Sedated Patients for Colonoscopy: Midazolam and Propofol or Fentanyl and Propofol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy is an important diagnostic and therapeutic tool in colon disorders. Different&#xD;
      drugs and levels of sedation can be used in its accomplishment. There is no consensus on&#xD;
      which is the ideal. The aim of this study was to compare the post anesthetic recovery time&#xD;
      between patients deeply sedated with midazolam and propofol or fentanyl and propofol. 50&#xD;
      American Society of Anesthesiologist physical state (ASA) I and II candidates elective&#xD;
      colonoscopy at Luxembourg Hospital were divided into two groups A) midazolam and propofol or&#xD;
      B) fentanyl and propofol. Time of examination, post anesthetic recovery and discharge at&#xD;
      home, intercurrence and propofol consumption were compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized, double-blind study conducted in the complementary examination&#xD;
      department of the Luxembourg Hospital, approved by the ethics and research committee of the&#xD;
      Luxembourg Hospital / Mário Penna Foundation (CAAE: 56538616.2.3001.5121). The sample size&#xD;
      was calculated in 21 participants for each group, based on a previous study, considering a&#xD;
      standard deviation of 7.5, to detect a difference of 7.5 minutes, with a power of 90% and&#xD;
      significance level of 5% . To cover possible losses, two groups were set up with 25&#xD;
      participants: midazolam and propofol, B fentanyl and propofol. Patients were invited to&#xD;
      participate in physical status ASA I and II candidates for elective colonoscopy.&#xD;
&#xD;
      The randomization was done through the distribution of numbers generated by the site&#xD;
      www.random.org in two groups A and B, with a sweeping draw. All participants signed a free&#xD;
      and informed consent form. The syringes were previously prepared by the anesthesiology&#xD;
      resident with 3mg midazolam or 50 mcg fentanyl and double distilled water to make up to 5ml&#xD;
      volume. Patients received standard and oxygen monitoring by nasal catheter at 4 liters /&#xD;
      minute. The anesthesiologist in charge administered a syringe delivered by the resident&#xD;
      according to the randomization, without knowing which solution was followed, followed by 50&#xD;
      mg of propofol in increments of 20 mg until reaching the Ramsay stage 4 of sedation and then&#xD;
      the physician endoscopist was authorized to introduce the colonoscope. The patient was&#xD;
      maintained in this sedation plan until the device was withdrawn through further 20 mg&#xD;
      increments of propofol administered according to the subjective evaluation of the&#xD;
      anesthesiologist. Episodes of patient awakening, movement, oxygen saturation (SpO2) drop&#xD;
      below 90%, and need for ventilatory assistance were noted if they occurred. The time between&#xD;
      the introduction of the endoscope and its withdrawal was defined as the examination&#xD;
      time.Then, the patient was refered to the post-anaesthesia care unit 1(PACU 1) where remained&#xD;
      monitorized and supervised by a nurse technique and a doctor from anestehsiology team until&#xD;
      reached the Aldrete Recovery Scale nine score. Reaching this criterion, the patient was&#xD;
      referred to post-anaesthesia care unit 2 (PACU 2) where he remained seated, without&#xD;
      monitoring and supplemental oxygen until he was able to walk,and drink water. Then he was&#xD;
      discharged from the hospital. This time was noted by another nursing technique: SRPA 2 Time.&#xD;
      Quantitative variables were submitted to the Shapiro-Wilk normality test, which is more&#xD;
      suitable for small samples. Data that presented normal distribution (parametric data) were&#xD;
      submitted to Student's t-Test. Non-parametric data were analyzed according to the Wilcoxon&#xD;
      Test. The Pearson Correlation Tests (parametric data) and Spearman (nonparametric data) were&#xD;
      used to evaluate the existence of a relationship (positive or negative) between two&#xD;
      variables. In all tests, the obtained differences were considered statistically significant&#xD;
      when the value of p was less than 0.05 (p &lt;0.05). The analyzes were performed using&#xD;
      GraphpadPrism®, version 5.0 for Windows.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">June 25, 2018</completion_date>
  <primary_completion_date type="Actual">June 25, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery time</measure>
    <time_frame>An average of two hours after the termination of the procedure.</time_frame>
    <description>The main objective was to compare post-anesthetic recovery times, defined as a score greater than or equal to 9 on the Aldrete scale, in patients submitted to two sedation regimens: midazolam with propofol or fentanyl with propofol. Aldrete scale is a post anesthesic recovery scale that ranges from 0 to 10, meaning complete recovery in values above nine.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Midazolam group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Midazolam and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist . Complications and procedure and recovery times were recorded for comparison with the Fentanyl group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fentanyl and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist .Complications and procedure and recovery times have were recorded for comparison with the Midazolam group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Administration of midazolam by anesthesiologist for sedation.</description>
    <arm_group_label>Midazolam group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Administration of fentanyl by anesthesiologist for sedation.</description>
    <arm_group_label>Fentanyl group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Administration of propofol by anesthesiologist for sedation.</description>
    <arm_group_label>Fentanyl group</arm_group_label>
    <arm_group_label>Midazolam group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II physical status patients scheduled for elective colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI less than 17 or over 30&#xD;
&#xD;
          -  allergy to any medication used,&#xD;
&#xD;
          -  cognitive difficulty,&#xD;
&#xD;
          -  psychiatric disorder,&#xD;
&#xD;
          -  hospitalization,&#xD;
&#xD;
          -  chronic use of opioids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renato Gomez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Minas Gerais</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Luxemburgo Hospital</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30380-472</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Renato Santiago Gomez</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Fentanyl</keyword>
  <keyword>Midazolam</keyword>
  <keyword>Propofol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT03813303
org study id: CAAE56538616230015121
nct id: NCT03813303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Colonoscopy is an important diagnostic and therapeutic tool in colon disorders. Different
      drugs and levels of sedation can be used in its accomplishment. There is no consensus on
      which is the ideal. The aim of this study was to compare the post anesthetic recovery time
      between patients deeply sedated with midazolam and propofol or fentanyl and propofol. 50
      American Society of Anesthesiologist physical state (ASA) I and II candidates elective
      colonoscopy at Luxembourg Hospital were divided into two groups A) midazolam and propofol or
      B) fentanyl and propofol. Time of examination, post anesthetic recovery and discharge at
      home, intercurrence and propofol consumption were compared.
A prospective, randomized, double-blind study conducted in the complementary examination
      department of the Luxembourg Hospital, approved by the ethics and research committee of the
      Luxembourg Hospital / Mário Penna Foundation (CAAE: 56538616.2.3001.5121). The sample size
      was calculated in 21 participants for each group, based on a previous study, considering a
      standard deviation of 7.5, to detect a difference of 7.5 minutes, with a power of 90% and
      significance level of 5% . To cover possible losses, two groups were set up with 25
      participants: midazolam and propofol, B fentanyl and propofol. Patients were invited to
      participate in physical status ASA I and II candidates for elective colonoscopy.

      The randomization was done through the distribution of numbers generated by the site
      www.random.org in two groups A and B, with a sweeping draw. All participants signed a free
      and informed consent form. The syringes were previously prepared by the anesthesiology
      resident with 3mg midazolam or 50 mcg fentanyl and double distilled water to make up to 5ml
      volume. Patients received standard and oxygen monitoring by nasal catheter at 4 liters /
      minute. The anesthesiologist in charge administered a syringe delivered by the resident
      according to the randomization, without knowing which solution was followed, followed by 50
      mg of propofol in increments of 20 mg until reaching the Ramsay stage 4 of sedation and then
      the physician endoscopist was authorized to introduce the colonoscope. The patient was
      maintained in this sedation plan until the device was withdrawn through further 20 mg
      increments of propofol administered according to the subjective evaluation of the
      anesthesiologist. Episodes of patient awakening, movement, oxygen saturation (SpO2) drop
      below 90%, and need for ventilatory assistance were noted if they occurred. The time between
      the introduction of the endoscope and its withdrawal was defined as the examination
      time.Then, the patient was refered to the post-anaesthesia care unit 1(PACU 1) where remained
      monitorized and supervised by a nurse technique and a doctor from anestehsiology team until
      reached the Aldrete Recovery Scale nine score. Reaching this criterion, the patient was
      referred to post-anaesthesia care unit 2 (PACU 2) where he remained seated, without
      monitoring and supplemental oxygen until he was able to walk,and drink water. Then he was
      discharged from the hospital. This time was noted by another nursing technique: SRPA 2 Time.
      Quantitative variables were submitted to the Shapiro-Wilk normality test, which is more
      suitable for small samples. Data that presented normal distribution (parametric data) were
      submitted to Student's t-Test. Non-parametric data were analyzed according to the Wilcoxon
      Test. The Pearson Correlation Tests (parametric data) and Spearman (nonparametric data) were
      used to evaluate the existence of a relationship (positive or negative) between two
      variables. In all tests, the obtained differences were considered statistically significant
      when the value of p was less than 0.05 (p <0.05). The analyzes were performed using
      GraphpadPrism®, version 5.0 for Windows.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Recovery time
time frame: An average of two hours after the termination of the procedure.
description: The main objective was to compare post-anesthetic recovery times, defined as a score greater than or equal to 9 on the Aldrete scale, in patients submitted to two sedation regimens: midazolam with propofol or fentanyl with propofol. Aldrete scale is a post anesthesic recovery scale that ranges from 0 to 10, meaning complete recovery in values above nine.
arm group label: Midazolam group
arm group type: Active Comparator
description: Midazolam and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist . Complications and procedure and recovery times were recorded for comparison with the Fentanyl group.
arm group label: Fentanyl group
arm group type: Active Comparator
description: Fentanyl and Propofol administered for sedation in colonoscopy elective patients by anesthesiologist .Complications and procedure and recovery times have were recorded for comparison with the Midazolam group.
intervention type: Drug
intervention name: Midazolam
description: Administration of midazolam by anesthesiologist for sedation.
arm group label: Midazolam group
intervention type: Drug
intervention name: Fentanyl
description: Administration of fentanyl by anesthesiologist for sedation.
arm group label: Fentanyl group
intervention type: Drug
intervention name: Propofol
description: Administration of propofol by anesthesiologist for sedation.
arm group label: Fentanyl group
arm group label: Midazolam group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Renato Gomez
role: Principal Investigator
affiliation: Federal University of Minas Gerais
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Renato Santiago Gomez
investigator title: Clinical Professor
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Propofol
sharing ipd: No