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

Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Reaction
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

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
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine, Ain-Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: ketamine
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.	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 Names: ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
induction time	Time to reach target Ramsay Sedation Score ≥ 3	after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached
Recovery time	time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening	after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening

Collaborators and Investigators

• Sponsor: Tamer Nabil Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Propofol; Dexmedetomidine
• Other Study ID Numbers: FAMSU R 21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No