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Intravenous Dexmedetomidine versus Nebulised Dexmedetomidine for procedural sedation during ERCP

Intravenous Dexmedetomidine versus Nebulised Dexmedetomidine in combination with standardised Propofol-Fentanyl-Midazolam for Procedural sedation during ERCP: a comparative evaluation of sedation efficacy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221109056455N2
Enrollment
70
Registered
2024-09-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

choledocholithiasis with obstruction. Other cholelithiasis with obstruction

Interventions

Intervention 1: Intervention group: Group NEB-DEX will receive nebulized dexmedetomidine 1 µg/kg diluted in normal saline (0.9%) to a volume of 5 ml 30 minutes prior to induction of anesthesia. Interv

Sponsors

Tata Main Hospital, Jamshedpur
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patient undergoing procedural sedation for Endoscopic retrograde cholangio- pancreaticography ASA physical status 1- 3 AGE 18-65 Years

Exclusion criteria

Exclusion criteria: Patient refusal allergy to study drugs Heart rate less than 50/minute Patient on beta blockers Hemodynamically unstable or shock. oxygen saturation less than 95 % on room air Hepatic or renal failure Second degree or third degree heart block BMI > 36 kg/m2

Design outcomes

Primary

MeasureTime frame
Propofol consumption per unit time. Timepoint: At the end of procedure. Method of measurement: Propofol consumption will be calculated by sum of amount consumed by infusion and rescue bolus doses of propofol. It will be divided by duration of infusion to calculate per unit time propofol consumption.

Secondary

MeasureTime frame
Patient satisfaction score. Timepoint: at the end of procedure. Method of measurement: Patient satisfaction will be assessed using 5 point Gloucester Comfort Score.;Incidence of Adverse event( Desaturation, hypotension and bradycardia). Timepoint: At the end of procedure. Method of measurement: Hypotension will be defined by blood pressure falling more than 20 % of baseline as measured by sphygmomanometer. Bradycardia will be counted if heart rate is less than 50 during the procedure. If saturation fall below 95 during procedure, it will be counted as desaturation episode.

Countries

India

Contacts

Public ContactDr Rishi Anand

Tata Main Hospital, Jamshedpur

rishi.anand1@tatasteel.com+91 97165 48587

Outcome results

None listed

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