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

Phase 4

Completed

• Conditions: Anesthesia; Reaction
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT04906772
• Lead Sponsor: Tamer Nabil Abdelrahman

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 Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-02-27
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Primary Completion: 2021-07-13
• Study Completion: 2021-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group KD	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.
Group KP	Propofol	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.

Primary Outcome Measures

Name	Time	Method
induction time	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	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

Trial Locations

Locations (1)

Faculty of medicine, Ain-Shams university; 🇪🇬 Cairo, Egypt