Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine- Propofol Versus Pethidine- Propofol in ERCP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651792
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
khaled salah mohamed, Assiut University

Tracking Information
First Submitted Date  ICMJE November 29, 2015
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date April 29, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition) [ Time Frame: Immediately after procedure. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2016)
amount of propofol consumed during procedure [ Time Frame: Immediately after procedure. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine- Propofol Versus Pethidine- Propofol in ERCP
Official Title  ICMJE Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Brief Summary The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.
Detailed Description The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Sedation in ERCP
Intervention  ICMJE
  • Drug: ketamine- propofol
    1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.
    Other Name: N01AX03 - Propofol
  • Drug: pethidine- propofol
    1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
    Other Name: meperidine - Propofol
Study Arms  ICMJE
  • Active Comparator: ketamine- propofol
    IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.
    Intervention: Drug: ketamine- propofol
  • Active Comparator: pethidine- propofol
    1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
    Intervention: Drug: pethidine- propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • both gender
  • age between 18-70

Exclusion Criteria:

  • pregnant patients.
  • morbid obesity.
  • chronic obstructive pulmonary disease.
  • complicated airway.
  • American society of anesthesia (ASA) physical classification IV-V.
  • history of allergy or contraindications to the drugs used in the study
  • emergency need for ERCP.
  • those whose informed consent could not be signed.
  • those with possible complex ERCP.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651792
Other Study ID Numbers  ICMJE ketfol versus pethidine
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party khaled salah mohamed, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mostafa S Abbas, MD Assiut University
PRS Account Assiut University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP