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

NCT ID: NCT04906772

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2021-09-30

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.

Conditions

Anesthesia; Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ketamine; ketamine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tamer Nabil Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Tamer Nabil Abdelrahman

lecturer of anaesthesia, intensive care and pain management

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of medicine, Ain-Shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FAMSU R 21

Identifier Type: -

Identifier Source: org_study_id