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Comparison of Safety and efficacy of two drug combination for sedation during gastro-intestinal endoscopy.

Safety and efficacy of ketamine-dexmedetomidine combination versus ketamine-propofol combination for sedation during ERCP: an open-label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020625
Enrollment
80
Registered
2019-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: Combination of ketamine and dexmedetomidine: Patients will receive a loading dose of dexmedetomidine 1 mcg/kg over 10 minutes. This will be followed by injection of ketamine 0.5 mg/kg.

Sponsors

All India Institute of Medical Science New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)ASA I & II Patients b)Age 18 - 65 years

Exclusion criteria

Exclusion criteria: a) Refusal of consent. b) Pregnancy. c) Pre-existing cardiac arrhythmias. d) Ischemic heart disease. e) Hypertension. f) Basal heart rate g) Patient on �-blockers. h) Renal or liver insufficiency.

Design outcomes

Primary

MeasureTime frame
To determine the difference in the mean SpO2 following administration of ketamine-dexmedetomidine combination as opposed to ketamine-propofol combination for sedation in patients undergoing ERCP.Timepoint: From Induction of IV Sedation to 4hrs After Procedure

Secondary

MeasureTime frame
Between the two groups, to determine - The number of times rescue boluses are needed. The changes in heart rate and mean arterial pressure. The number of episodes of significant respiratory depression. The Endoscopistâ??s satisfaction. Time taken to achieve score of 3 on Ramsay sedation scale after stopping infusions. Pain scores following procedure. Time taken to achieve discharge criteria. Timepoint: From Induction of IV Sedation to 4hrs After Procedure

Countries

India

Contacts

Public ContactAjay Singh

All India Institute of Medical Science, New Delhi

ajay.ydv2509@gmail.com9999276845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026