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Comparison of Propofol-Fentanyl and Propofol-Dexmedetomidine combinations for sedation in ERCP

A Bispectral index guided comparison of Propofol-Fentanyl and Propofol-Dexmedetomidine combinations for intravenous sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/054292
Enrollment
82
Registered
2023-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Control Intervention1: NIL: NIL

Sponsors

WASIM WAHID
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing ERCP under iv sedation 1)ASA physical status I,II and III 2)Body weight :40 to 70 kg

Exclusion criteria

Exclusion criteria: 1) Allergy or history of adverse reaction to Propofol, Dexmedetomidine or Fentanyl 2) Pregnancy or lactation 3) Anticipated difficult airway 4) Patients with chronic kidney disease, neurological deficit, pre-existing delirium/cognitive dysfunction 5) Evidence of hepatic encephalopathy or ascites 6) Hyponatremia ( 5.5 meq/l) 7) Patient refusal 8) Patients with comorbidities like uncontrolled hypertension, hypotension, uncontrolled diabetes mellitus, congestive cardiac failure, and low cardiac output disorders or arrhythmias.

Design outcomes

Primary

MeasureTime frame
To assess and compare the onset of action, the quality of anaesthesia and recovery time produced by Propofol-Fentanyl and Propofol-Dexmedetomidine combinations in patients during ERCP with the help of BIS.Timepoint: Onset of action - after starting Propofol infusion (within 5 min of starting Propofol infusion) Quality of anaesthesia - From 0 min to the procedure ending time Recovery time - From removal of the endoscope to the time when patient becomes awake/ BIS value greater than 90

Secondary

MeasureTime frame
1) To compare the hemodynamic changes produced by Propofol-Fentanyl and Propofol-Dexmedetomidine combinations during sedation in ERCP at 0,3,5 and 15 minutes respectively 2) To assess the adverse effects produced by the two combinations 3) To assess and compare the physician/patient satisfaction in each combinations. Timepoint: 0, 3, 5 and 15 minutes after starting Propofol infusion and till one hour post-procedure

Countries

India

Contacts

Public ContactSURUMA YOUSUF KUNJU

K S HEGDE MEDICAL ACADEMY

gaibhat@gmail.com8113920015

Outcome results

None listed

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