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

Sponsor

Tamer Nabil Abdelrahman (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04906772

Collaborator

(none)

Enrollment

Location

Arms

5.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Reaction	Drug: Dexmedetomidine Drug: Propofol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 3, 2021

Anticipated Primary Completion Date :

Jul 13, 2021

Anticipated Study Completion Date :

Jul 30, 2021

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Ain-Shams university	Cairo		Egypt

Sponsors and Collaborators

Tamer Nabil Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Nabil Abdelrahman, lecturer of anaesthesia, intensive care and pain management, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04906772

Other Study ID Numbers:

FAMSU R 21

First Posted:

May 28, 2021

Last Update Posted:

May 28, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dexmedetomidine

Ketamine

Propofol

Study Results

No Results Posted as of May 28, 2021