<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/NCT03260283</url>
  </required_header>
  <id_info>
    <org_study_id>StSavvasAH 2</org_study_id>
    <nct_id>NCT03260283</nct_id>
  </id_info>
  <brief_title>Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.</brief_title>
  <official_title>Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Savvas Anticancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Savvas Anticancer Hospital</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>
      The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of&#xD;
      pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is&#xD;
      nowadays the common practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 29, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>Double blind randomized control trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.</measure>
    <time_frame>30 minutes after the intrathecal administration of the drug</time_frame>
    <description>Low dose of pethidine hydrochloride will be administered for subarachnoid anesthesia in patients subjected to urologic operations.The level of sensory block after subarachnoid anesthesia will be assessed by the pinprick test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.</measure>
    <time_frame>30 minutes after the intrathecal administration of the drug</time_frame>
    <description>The level of motor block will be assessed by the modified Bromage scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the time of motor block establisment.</measure>
    <time_frame>30 minutes after the intrathecal administration of the drug</time_frame>
    <description>Time of motor block establishment (Grade 2 in modified Bromage scale) will be recorded as well as the time of withdrawal. Failure of spinal block is considered when there is no block at the level of first lumbar vertebra 30 minutes after the intrathecal administration of the drugs and in these cases the patients are excluded from the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.</measure>
    <time_frame>In the first 24 hours postoperatively</time_frame>
    <description>In order to assess the efficacy of analgesia provided by the low dose of pethidine hydrochloride we record the time at which patients ask analgesic for the first time after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of postsurgical catheter-related bladder discomfort</measure>
    <time_frame>Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively</time_frame>
    <description>Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of haemodynamic status of patients intraoperatively</measure>
    <time_frame>During the operation</time_frame>
    <description>In order to assess the haemodynamic status of patients intraoperatively we record all episodes of hypotension (drop of systolic pressure &gt;30% of value before the subarachnoid block.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in postanesthesia care unit</measure>
    <time_frame>Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.</time_frame>
    <description>We record the total amount of time that patients stay in the postanesthesia care unit immediately after the operation until they are discharged to the ward. In order for a patient to be discharged to the ward he must have a score of more than &gt;9 in Aldrete's Scoring system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>All adverse events observed intraoperatively and in the first 24 hours postoperatively</time_frame>
    <description>We record all adverse events observed intraoperatively and 24 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.</measure>
    <time_frame>In the first 24 hours postoperatively</time_frame>
    <description>We also record the total amount of analgesics administered in morphine analogues in the first 24 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of haemodynamic status of patients intraoperatively</measure>
    <time_frame>During the operation</time_frame>
    <description>We also record the total amount of intravenous fluids administered intraoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Low Dose of Pethidine for Subarachnoid Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.4 mgkg-1 of pethidine hydrochloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2ml of ropivacaine (0.75%) with 15 mcg of fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pethidine hydrochloride</intervention_name>
    <description>In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine HCl Inj 7.5 MG/ML</intervention_name>
    <description>In Group II patients will be administered with 2 ml of ropivacaine (0.75%)</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients about to be subjected to Transurethral resection of the prostate (TURP)&#xD;
             and Transurethral resection of urinary bladder tumors (TUR)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  When subarachnoid block is contraindicated&#xD;
&#xD;
          -  Patient's denial in performing subarachnoid anesthesia&#xD;
&#xD;
          -  Failure of subarachnoid block (L1 dermatome in 30 minutes after intrathecal drug&#xD;
             administration)&#xD;
&#xD;
          -  Mental illness or drug abuse&#xD;
&#xD;
          -  Estimated time of operation &gt;90 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sofia Poulopoulou, Head of department</last_name>
    <role>Study Director</role>
    <affiliation>Anticancer Hospital of Athens 'Saint Savvas'</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anticancer Hospital of Athens &quot;Saint Savvas&quot;</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Luck JF, Fettes PD, Wildsmith JA. Spinal anaesthesia for elective surgery: a comparison of hyperbaric solutions of racemic bupivacaine, levobupivacaine, and ropivacaine. Br J Anaesth. 2008 Nov;101(5):705-10. doi: 10.1093/bja/aen250. Epub 2008 Sep 2.</citation>
    <PMID>18765643</PMID>
  </reference>
  <reference>
    <citation>Mohta M. Ropivacaine: Is it a good choice for spinal anesthesia? J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):457-8. doi: 10.4103/0970-9185.169050. No abstract available.</citation>
    <PMID>26702199</PMID>
  </reference>
  <reference>
    <citation>Lewis RP, Spiers SP, McLaren IM, Hunt PC, Smith HS. Pethidine as a spinal anaesthetic agent--a comparison with plain bupivacaine in patients undergoing transurethral resection of the prostate. Eur J Anaesthesiol. 1992 Mar;9(2):105-9.</citation>
    <PMID>1555549</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 28, 2020</last_update_submitted>
  <last_update_submitted_qc>March 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Savvas Anticancer Hospital</investigator_affiliation>
    <investigator_full_name>Georgia Micha</investigator_full_name>
    <investigator_title>Anesthesiologist,MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>pethidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Meperidine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03260283
org study id: StSavvasAH 2
nct id: NCT03260283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of
      pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is
      nowadays the common practice.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind randomized control trial
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.
time frame: 30 minutes after the intrathecal administration of the drug
description: Low dose of pethidine hydrochloride will be administered for subarachnoid anesthesia in patients subjected to urologic operations.The level of sensory block after subarachnoid anesthesia will be assessed by the pinprick test.
measure: Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.
time frame: 30 minutes after the intrathecal administration of the drug
description: The level of motor block will be assessed by the modified Bromage scale.
measure: Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the time of motor block establisment.
time frame: 30 minutes after the intrathecal administration of the drug
description: Time of motor block establishment (Grade 2 in modified Bromage scale) will be recorded as well as the time of withdrawal. Failure of spinal block is considered when there is no block at the level of first lumbar vertebra 30 minutes after the intrathecal administration of the drugs and in these cases the patients are excluded from the study.
measure: Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
time frame: In the first 24 hours postoperatively
description: In order to assess the efficacy of analgesia provided by the low dose of pethidine hydrochloride we record the time at which patients ask analgesic for the first time after the operation.
measure: Percentage of postsurgical catheter-related bladder discomfort
time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
description: Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)
measure: Assessment of haemodynamic status of patients intraoperatively
time frame: During the operation
description: In order to assess the haemodynamic status of patients intraoperatively we record all episodes of hypotension (drop of systolic pressure >30% of value before the subarachnoid block.
measure: Length of stay in postanesthesia care unit
time frame: Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.
description: We record the total amount of time that patients stay in the postanesthesia care unit immediately after the operation until they are discharged to the ward. In order for a patient to be discharged to the ward he must have a score of more than >9 in Aldrete's Scoring system.
measure: Adverse events
time frame: All adverse events observed intraoperatively and in the first 24 hours postoperatively
description: We record all adverse events observed intraoperatively and 24 hours postoperatively
measure: Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
time frame: In the first 24 hours postoperatively
description: We also record the total amount of analgesics administered in morphine analogues in the first 24 hours postoperatively.
measure: Assessment of haemodynamic status of patients intraoperatively
time frame: During the operation
description: We also record the total amount of intravenous fluids administered intraoperatively.
arm group label: Group I
arm group type: Experimental
description: 0.4 mgkg-1 of pethidine hydrochloride
arm group label: Group II
arm group type: Experimental
description: 2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
intervention type: Drug
intervention name: Pethidine hydrochloride
description: In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations
arm group label: Group I
intervention type: Drug
intervention name: Ropivacaine HCl Inj 7.5 MG/ML
description: In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
arm group label: Group II
intervention type: Drug
intervention name: Fentanyl
description: 15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations
arm group label: Group II
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Sofia Poulopoulou, Head of department
role: Study Director
affiliation: Anticancer Hospital of Athens 'Saint Savvas'
facility: 
country: Greece
citation: Luck JF, Fettes PD, Wildsmith JA. Spinal anaesthesia for elective surgery: a comparison of hyperbaric solutions of racemic bupivacaine, levobupivacaine, and ropivacaine. Br J Anaesth. 2008 Nov;101(5):705-10. doi: 10.1093/bja/aen250. Epub 2008 Sep 2.
PMID: 18765643
citation: Mohta M. Ropivacaine: Is it a good choice for spinal anesthesia? J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):457-8. doi: 10.4103/0970-9185.169050. No abstract available.
PMID: 26702199
citation: Lewis RP, Spiers SP, McLaren IM, Hunt PC, Smith HS. Pethidine as a spinal anaesthetic agent--a comparison with plain bupivacaine in patients undergoing transurethral resection of the prostate. Eur J Anaesthesiol. 1992 Mar;9(2):105-9.
PMID: 1555549
responsible party type: Principal Investigator
investigator affiliation: Saint Savvas Anticancer Hospital
investigator full name: Georgia Micha
investigator title: Anesthesiologist,MD, MSc, PhD
mesh term: Fentanyl
mesh term: Meperidine
mesh term: Ropivacaine
sharing ipd: Undecided