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

Tamer Nabil Abdelrahman

Status and phase: Completed; Phase 4

Conditions: Anesthesia; Reaction

Treatments: Drug: Dexmedetomidine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04906772

FAMSU R 21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Group KD

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Group KP

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol