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Determination and comparision of effective dose of Propofol combined with Fentanyl and Propofol combined with Remifentanyl in order to find the optimal sedation dose in sedation in Upper Gastrointestinal endoscopic procedures

Optimal Sedation Analgesia In Upper Gastrointestinal Endoscopic Interventions Determination and Comparison of Median Effective Target Concentration of Propofol In Combination With Fentanyl versus Remifentanil PERFS - PERFS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082667
Enrollment
280
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: Remifentanil TCI.: Remifentanil will be administered along with propofol target controlled infusion for analgesic component. Control Intervention1: Fentanyl Bolus: Fentanyl boluses will

Sponsors

Dr Shikhar More
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18-70 years undergoing upper GI endoscopic interventions (ERCP and EUS-FNA) ASA (American Society of Anesthesiologists) physical status I-III.

Exclusion criteria

Exclusion criteria: History of allergy to study drugs. Severe cardiovascular, respiratory, hepatic or renal disease. Pregnancy and lactation. BMI less than 18 or more than 35 Psychiatric illness or liver dysfunction leading to altered sensorium Documented OSA Anticipated difficult airway

Design outcomes

Primary

MeasureTime frame
Incidence of sedation related adverse events (SRAE).Timepoint: Periprocedure—

Secondary

MeasureTime frame
ED50 and ED90 of propofol in both groups. Incidence of unsuccessful sedation Recovery time Endoscopist satisfaction Patient satisfaction Mean total Propofol consumption Timepoint: Periprocedural—

Countries

India

Contacts

Public ContactDr Shikhar More

Consultant, Department of Onco-Anaesthesia and Pain, Tata Medical Center, Kolkata, India

shikharmore@gmail.com8521890962

Outcome results

None listed

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