Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)
Overview
- Phase
- Phase 4
- Intervention
- Dexmedetomidine
- Conditions
- Anesthesia; Reaction
- Sponsor
- Tamer Nabil Abdelrahman
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- induction time
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tamer Nabil Abdelrahman
lecturer of anaesthesia, intensive care and pain management
Ain Shams University
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
Arms & Interventions
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: Dexmedetomidine
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: Propofol
Outcomes
Primary Outcomes
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