To compare the safety and efficacy of Remifentanil with Fentanyl for pain relief during induction and maintenance of general anesthesia

Phase 3

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2021/01/030800
• Lead Sponsor: Themis Medicare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 321

Inclusion Criteria

1. Subjects of either sex in the age group

between 18 to 65 years(inclusive) at the time

of signing ICF.

2. Subject scheduled for elective therapeutic and

diagnostic surgical procedure with estimated

duration of at least 30 minutes and up to

approximately 120 minutes with an American

society of anesthesiologists (ASA) physical

status scale ranging from ASA1 or ASA2 and

required hospitalization for at least 24

hours.

3. Subjects who provide a written informed

consent to abide by the study requirements.

Exclusion Criteria

1.Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anaesthesia.

2.Subjects with BMI > 35.

3.Subjects on regular oral benzodiazepines drugs.

4.Subjects suffering from known organic neurological disorders, psychiatric illnesses with or without treatment and history of drug abuse and history of alcohol abuse.

5.Subjects with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.

6.Subjects treated with ACE inhibitor and Angiotensin II receptor blockers (ARBs) within 24 hours before procedure. (Subject can be switched to Calcium channel blockers or Beta blockers if required)

7.Subjects receiving Gabapentin and pregabalin.

8.Subjects with known hypersensitivity to any of the ingredients of the test / comparator formulation.

9.Subjects whose screening lab values are exceeding the upper limit of normal range significantly

10.Subjects who have positive serology tests.

11.Pregnant and lactating females.

12.Subjects simultaneously participating in another clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified