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

NCT04906772 | Completed Phase 4 DMC

• 1 other identifier: FAMSU R 21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Reaction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group KD

EXPERIMENTAL

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

Group KP

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Also known as: ketamine

Group KD

Propofol DRUG

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.

Also known as: ketamine

Group KP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tamer Nabil Abdelrahman: lead

Study Sites (1)

Faculty of medicine, Ain-Shams university

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of anaesthesia, intensive care and pain management

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: May 28, 2021
• Study Start: February 3, 2021
• Primary Completion: July 13, 2021
• Study Completion: September 30, 2021
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

EG (1)