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Dexmedetomidine Versus Ketofol for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography

NCT06212401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-01-18

No results posted yet for this study

Summary

Patients were randomly divided into Dexmedetomidine or Ketofol for sedation. In patients who received Dexmedetomidine, a 2ml ampule of 100 ug/ml was diluted in 18 ml of normal saline, making a total volume of 20 ml. Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr and it was labeled as "infusion 1". In the Ketofol group, 2 ml ketamine (50mg/ml) and 10 ml of propofol 1% (10mg/ml) were diluted in 8ml of normal saline. This mixture was 20 ml each, making 5mg/ml of ketamine and propofol. Patients received 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion, labeled as "infusion 2".

Conditions

  • Sedation

Interventions

DRUG

Dexmedetomidine

Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr

DRUG

Ketofole

Patients received ketofol 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion

Sponsors & Collaborators

  • Sindh Institute of Urology and Transplantation

    lead OTHER

Principal Investigators

  • Syed M Abbas, FCPS · Sindh Institute of Urology and Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212401 on ClinicalTrials.gov