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A clinical trial comparing the effectiveness of sedation between Etomidate-Ketamine and Propofol-Ketamine during ERCP procedure

Comparison of Etomidate-Ketamine versus Propofol-Ketamine for Procedural Sedation during Endoscopic Retrograde Cholangiopancreatography: A Randomized Single Blind Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089648
Enrollment
88
Registered
2025-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Etomidate - Ketamine: An initial intravenous injection of ketamine at a dose of 1 mg/kg was administered, followed by a slow intravenous bolus of etomidate at a dose of 0.15 mg/kg. Seda

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II Undergoing elective ERCP procedure

Exclusion criteria

Exclusion criteria: Patients with allergies to study drugs Patients refusal to participate in the study Patients with allergies to study drugs pregnant patients Patients with neurological or psychiatric conditions Patients with anticipated difficult airway or OSA Patients with glaucoma Patients with uncontrolled systemic diseases

Design outcomes

Primary

MeasureTime frame
Patient movementTimepoint: At the time of endoscopic insertion

Secondary

MeasureTime frame
Onset time of the target sedationTimepoint: at the time of attaining an RSS score of 4 or more;Requirement of rescue analgesia (timing and amount)Timepoint: NIL;Total amount of study drugs being usedTimepoint: NIL;HR, MAP, SpO2, RR, RSS & BISTimepoint: At Baseline (T0), at the time of attaining an RSS score of 4 or more (T1), at the time of insertion of the endoscope (T2), at 5 minutes from T1 (T3), at 10 minutes from T1 (T4), at 20 minutes from T1 (T5), at 30 minutes from T1 (T6), at the time of withdrawal of the endoscope (T7), before shifting to the recovery room (T8), & at the time of attaining a modified Aldrete score of 9 or more, excluding BIS (T9);Patient movement at the time of removal of the endoscopeTimepoint: NIL;Recovery timeTimepoint: time from the end of the ERCP procedure to attain a modified Aldrete score of 9 or more;Assess the overall satisfaction of the endoscopist and patient as well as pain and procedure memory scoreTimepoint: NIL;Total duration of the anaesthesia and intervention procedureTimepoint: NIL;Peri-procedural complications (Desaturation, Hypotension/Hypertension, Bradycardia, Myoclonus, Nausea and Agitation)Timepoint: NIL

Countries

India

Contacts

Public ContactAmiya Kumar Barik

Post Graduate Institute of Medical Education and Research

amiyabarik.scb@gmail.com8052919523

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026