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

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

Tracking Information

• First Submitted Date: February 27, 2021
• First Posted Date: May 28, 2021
• Last Update Posted Date: May 28, 2021
• Actual Study Start Date: February 3, 2021
• Estimated Primary Completion Date: July 13, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Anesthesia; Reaction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 25, 2021): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2021
• Estimated Primary Completion Date: July 13, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04906772
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Tamer Nabil Abdelrahman, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Tamer Nabil Abdelrahman
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ain Shams University
• Verification Date: May 2021