To compare effect of Dexmedetomidine and Remitentanil in patients posted for Endoscopic Retrograde cholangiography (ERCP)

A comparative study of effect of Dexmedetomidine and Remifentanil infusion for patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). A Double blind randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089426

Enrollment

118

Registered

2025-06-24

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: -

Interventions

Intervention1: Remifentanil: Inj.Remifentanil 1 mcg/kg intravenously bolus for 1 minute followed by infusion of 0.15-0.5 mcg/kg/hour during the surgery. Control Intervention1: Dexmedetomidine: Inj.Dex

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients age between 18 to 60 undergoing for ERCP 2) ASA physical status I-II

Exclusion criteria

Exclusion criteria: 1) Neurological disease 2) Psychiatric disease 3) Cardiovascular disease (Arrhythmia, Heart failure, coronary artery disease) 4) Anticipated difficult airway 5) Pulmonary disease (asthma, COPD) 6) Pregnant patients 7) Known allergy to study drugs

Design outcomes

Primary

Measure	Time frame
To estimate the dose of Propofol during procedureTimepoint: Duration of Surgery	—

Secondary

Measure	Time frame
To evaluate Haemodynamic stability (MAP, Heart Rate)Timepoint: Duration of Surgery;Incidence of Respiratory depression (SpO2 less than less 90% or Respiratory rate less than 8 per minute)Timepoint: Duration of Surgery;Ramsay sedation scoreTimepoint: At the end of procedure and at 1 hour post operative period;Incidence of side effect (Nausea, Vomiting and Delirium)Timepoint: Post operative period for 1 hour	—

Measure

Time frame

To evaluate Haemodynamic stability (MAP, Heart Rate)Timepoint: Duration of Surgery;Incidence of Respiratory depression (SpO2 less than less 90% or Respiratory rate less than 8 per minute)Timepoint: Duration of Surgery;Ramsay sedation scoreTimepoint: At the end of procedure and at 1 hour post operative period;Incidence of side effect (Nausea, Vomiting and Delirium)Timepoint: Post operative period for 1 hour

—

Countries

India

Contacts

Public ContactDr Deep Trambadiya

Institute of medical science and sum hospital

drswastika81@yahoo.com9861628628

Outcome results

None listed

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