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Comparing Dexmedetomidine and Midazolam for Better Premedication in Ketofol Anesthesia During Endoscopic Retrograde Cholangiopancreatography (ERCP)

comparative study of Dexmedetomidine with Midazolam as premedication to Ketamine-Propofol (Ketofol) Anaesthesia in ERCP - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076738
Enrollment
60
Registered
2024-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: Inj Midazolam: Inj Midazolam at 0.05mg/kg IV bolus 10 min before , along with intermittent 10 mg Ketofol (1:1) boluses until RSS 4 achieved , as premedication to Ketamine-Propofol (Keto

Sponsors

Teerthanker Mahaveer Medical College and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient giving written and informed consent. 2 American Society of Anesthesiologist (ASA) Grade I-III. 3.Age group of 18-65 years

Exclusion criteria

Exclusion criteria: 1.Pregnant patients and BMI over 36kg/m2 2.Allergy or intolerance to Drugs administered. 3.Chronic alcohol and drug abuse.

Design outcomes

Primary

MeasureTime frame
To calculate the requirement of Ketofol using Dexmedetomedine and Midazolam as premedication for ERCP. To compare the post operative recovery time during ERCP in both the groups To compare quality of sedation during ERCP in both the groups. Timepoint: 1hr 2hr 3hr 4hr

Secondary

MeasureTime frame
To compare hemodynamic stability during ERCP in both the groups. To assess the degree of comfort by patient and Endoscopist. To compare associated complications in both the groupsTimepoint: 5min 10min 15min 20min 25min 30min 35min 40min 45min 50min 60min

Countries

India

Contacts

Public ContactDr MD Shahbaz Alam

Teerthanker Mahaveer Medical College and Research Center

dralamshahbaz006@gmail.com9897907372

Outcome results

None listed

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