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Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients

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: NCT04906772
Recruitment Status : Active, not recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Tamer Nabil Abdelrahman, Ain Shams University

Tracking Information
First Submitted Date  ICMJE February 27, 2021
First Posted Date  ICMJE May 28, 2021
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE February 3, 2021
Estimated Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
  • induction time [ Time Frame: after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached ]
    Time to reach target Ramsay Sedation Score ≥ 3
  • Recovery time [ Time Frame: after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening ]
    time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients
Official Title  ICMJE Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)
Brief Summary We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.
Detailed Description 70 Patients will be randomly allocated into two groups; Group (KD): Ketamine/dexmedetomidine (35 patients), will receive IV ketamine 0.25mg/kg and dexmedetomidine1µg/kg over 10 min as loading followed by dexmedetomidine infusion with a rate of 0.5µg/kg/hr and Group (KP): ketamine/propofol (35 patients) will receive IV ketamine 0.25 mg/kg loading and propofol 1 mg/kg over 10 min followed by propofol infusion with a rate of 0.5 mg/kg/hr as a control group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia; Reaction
Intervention  ICMJE
  • Drug: Dexmedetomidine
    participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
    Other Name: ketamine
  • Drug: Propofol
    participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
    Other Name: ketamine
Study Arms  ICMJE
  • Experimental: Group KD
    participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Group KP
    participants received loading of ketamine 1 mg/kg and propofol 1 mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25 µg/kg/hr dexmedetomidine throughout the procedure.
    Intervention: Drug: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2021)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2021
Estimated Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • hepatic patients with child-Pugh classification (class A), and (class B)
  • American Society of Anesthesiologists physical status II, III
  • aged 18 to 60 years
  • scheduled for elective Upper gastro-intestinal endoscopy.

Exclusion Criteria:

  • emergency gastro-intestinal endoscopy.
  • patients with severe hepatic disorder (Child C) ,
  • chronic neuro-psychiatric disorder,
  • history of neuro-psychiatric drug intake,
  • severe cardiovascular diseases,
  • pregnancy,
  • history of drug abuse, and
  • history of allergy to any of the used drugs in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT04906772
Other Study ID Numbers  ICMJE FAMSU R 21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tamer Nabil Abdelrahman, Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tamer Nabil Abdelrahman
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date May 2021

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