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COMPARATIVE STUDY BETWEEN TWO GROUPS,BOTH GROUPS RECEIVING DIFFERENT DRUG COMBINATIONS, IN PATIENTS UNDERGOING ERCP

Comparative study between two groups, one receiving propofol & fentanyl and the other receiving propofol & midazolam , in patients undergoing endoscopic retrograde cholangiopancreatography(ERCP):a randomized controlled study - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/057038
Enrollment
100
Registered
2023-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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 Health Condition 2: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Injecting anaesthetic drugs propofol and fentanyl: Intra procedural(for an average procedure time of 30-60 minutes) and post procedural(60 minutes after procedure) haemodynamic and resp

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective and emergency ERCP, who have provided written informed consent and belonging to ASA CLASS 1 AND 2

Exclusion criteria

Exclusion criteria: 1) Patient Refusal 2) Patient having sensory or motor deficit 3) Patients having compromised renal , pulmonary and cardiac status 4) patients on medications like hypnotics,narcotic analgesics and sedatives 5)patients having known allergy to study drugs 6)presence of hypotension or any other vascular disease 7)patients having primary or secondary steroid deficiency or patients on steroid medications 8) History of seizure disorders 9) Anticipated difficult airway 10)Patients with ASA Grade III-5

Design outcomes

Primary

MeasureTime frame
Changes in Heart Rate, Blood Pressure & Ecg every 5 minutes accompanied by respiratory profileTimepoint: INTRAPROCEDURAL

Secondary

MeasureTime frame
Analgesia/Recovery/Complications/Haemodynamic & Respiratory profileTimepoint: Postprocedural

Countries

India

Contacts

Public ContactDr Dibyendu Garai

Institute of Post Graduate Medical Education & Research, Kolkata

dibyendugarai.dg@gmail.com9433181485

Outcome results

None listed

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