A Prospective, multicenter, observer blind, randomized, 3 arm, parallel group, Phase III comparative study to evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia

Study Objective: To evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia.

Study Design: Prospective, multicenter, observer blind, randomized, 3 arm, parallel group, comparative study to evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia.

Subject will be divided into three groups

All subjects will receive Propofol and Sevoflurane as anesthetic agent.

Target Population: 321

Efficacy Parameters: Primary endpoint

To evaluate the adequacy of intra-operative analgesia as measured by hemodynamic response to noxious stimuli during

• Laryngeal Intubation

• Skin incision

• Skin closure

• Extubation

Secondary endpoint

1. Number of Subjects who experienced muscle rigidity

2. No. of additional doses of propofol or any study drugs required during the entire surgical procedure period.

3. No. of subjects who required vasopressors drugs like mephenteramine.

4. No. of subjects who required anticholinergic drugs like atropine and Glycopyrrolate

5. Number of subjects who required naloxone administration.

Safety parameters:

1. Biochemical Examinations- Hematological; CBC, ESR, SGOT, SGPT, serum proteins, A/G ratio, Alkaline phosphatase, serum bilirubin, random blood Glucose, BUN, S. Electrolytes and serum creatinine.

2. ECG

3. ADR Recording

4. Vitals- BP, Temperature, Heart rate (Pulse)

Assessment Schedule:-

The study will involve Screening (Day 0), Randomization, Day of surgery and IP administration (Day 1) and EOS (Day 2). Total study duration is 48 hours approximately (24 hours prior to surgery and 24 hours after the surgery).