Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Remifentanil Hydrochloride: Remifentanil, 1mg lyophilized powder will be diluted in 50ml normal saline to attain a concentration of 20mcg/ml
Control Intervention
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects who experienced a. Bradycardia b. Tachycardia c. Hypertension d. Hypotension e. Respiratory depression f. Agitation To evaluate the adequacy of intra-operative analgesia as measured by hemodynamic response to noxious stimuliTimepoint: ââ?¬Â¢ Laryngeal Intubation ââ?¬Â¢ Skin incision ââ?¬Â¢ Skin closure ââ?¬Â¢ Extubation Time points for the assessment will be on Day-1 between 30 to 120 mins. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: All haematological, investigations will be repeated 24 hours post surgery as applicable. Time point: On Day 2 (upto 24 hours post surgery as applicable) | — |
Countries
India
Contacts
Public ContactSangameshwar Iyer
Themis Medicare Limited
Outcome results
None listed