FindTrial
Sign In

Comparison of Breathing changes during Endoscopic procedure using two different medicines

A comparative study of sedation and respiratory effects during endoscopic retrograde cholangiopancreatography with propofol fentanyl versus dexmedetomidine ketamine - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106737
Enrollment
80
Registered
2026-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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: Fentanyl Propofol: FENTANYL 1 to 2 mcg/kg IV PROPOFOL 1 to 2 mg/kg IV followed by 1.5 to 4.5 mg/kg/hr infusion started on the lowest rate and titrated as needed Control Intervention1

Sponsors

Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients belonging to ASA physical status I (normal Healthy patient) and II (Patient with mild systemic disease). Patients posted for endoscopic retrograde cholangiopancreatography. Patients giving written informed consent to participate in the study. Patients belonging to the age group of 18 to 65 years, of both genders. Patients with a Body Mass Index (BMI) less than 35.

Exclusion criteria

Exclusion criteria: Patients with known or suspected obstructive sleep apnoea. Patients who are intubated prior to the procedure, or needing oxygen supplementation on a daily basis. Patients with a history of allergies to the study medications or their ingredients. Female patients who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
To compare sedation and respiratory effects in patients undergoing endoscopic retrograde pancreaticography with Propofol Fentanyl versus Dexmedetomidine Ketamine.Timepoint: at the end of the procedure, and every 10 minutes thereafter till 30 minutes—

Secondary

MeasureTime frame
To compare haemodynamic parameters (heart rate, mean arterial pressure) between the two groups. To compare the time to recovery using the Modified Aldrete Score. To compare post-procedural pain using the Numeric Rating Scale for pain. To compare the incidence of adverse events, including hypoventilation, apnoea, oxygen desaturation, hypotension, bradycardia, and requirement of airway interventions Timepoint: at the end of the procedure, and every 10 minutes thereafter till 30 minutes—

Countries

India

Contacts

Public ContactRhea Kapur

Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital

rheakapur98@gmail.com8527645446

Outcome results

None listed

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