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Comparision between routine and bispectral index ( parameter for measuring level of unconsciousness ) guided propofol anaesthesia during endoscopy procedure and effect of local anaesthesia along with intravenous diclofenac sodium in reducing doses of propofol

Propofol sedation during endoscopic retrograde cholangiopancreatography: A comparison between conventional versus bispectral index guided approach and effect of diclofenac sodium along with topical pharyngeal anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015839
Enrollment
90
Registered
2018-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Intervention1: Group B: Intravenous infusion of propofol will be administered for ERCP procedure titrated to BIS value 60-80. Intervention2: Group C: In group C, patients will receive i.v. 75 mg of in

Sponsors

DEPARTMENT OF ANAESTHESIA INSTITUTE OF LIVER AND BILIARY SCIENCE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I & ASA II patients between age group 18 to 65 yrs scheduled for ERCP procedure will be recruited for the study.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients will be excluded if they have 1) Age 65 yrs 2) ASA III & IV patients 3) Chronic Liver Disease 4) Pregnant patients 5) Patients with a history of (H/O) Drug abuse 6) Patients refusing consent 7) H/o Acute kidney injury 8) H/o allergy to propofol / lidocaine/ NSAIDS 9) Post liver transplant patients 10) Patients with h/o egg allergy

Design outcomes

Primary

MeasureTime frame
BIS monitoring along with pre procedure administration of topical pharyngeal anaesthesia & i.v. diclofenac sodium may be useful adjuvant technique in reducing the dose of propofol thereby reducing side effects and leading to early recovery during ERCP.Timepoint: Untill discharge from day care recovery room

Secondary

MeasureTime frame
BIS monitoring along with pre procedure administration of topical pharyngeal anaesthesia & i.v. diclofenac sodium may be useful adjuvant technique in reducing the dose of propofol thereby reducing side effects and leading to early recovery during ERCP.Timepoint: Untill discharge from day care recovery room

Countries

India

Contacts

Public ContactNIMJE GANESH RAMAJI

INSTITUTE OF LIVER AND BILIARY SCIENCE

ganesh.nimje8@gmail.com9503332784

Outcome results

None listed

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