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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04906772
Other study ID # FAMSU R 21
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 3, 2021
Est. completion date September 30, 2021

Study information

Verified date January 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 30, 2021
Est. primary completion date July 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Egypt Faculty of medicine, Ain-Shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Tamer Nabil Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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