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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04906772
Enrollment
70
Registered
2021-05-28
Start date
2021-02-03
Completion date
2021-09-30
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Reaction

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.

Interventions

DRUGDexmedetomidine

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.

DRUGPropofol

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.

Sponsors

Tamer Nabil Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
induction timeafter 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reachedTime to reach target Ramsay Sedation Score ≥ 3
Recovery timeafter 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye openingtime from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026