Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Remifentanil Hydrochloride 1mg/2mg for Injection: Remifentanil Hydrochloride 1mg/2mg for Injection(Remithem®)
Control Intervention1: Not applicable: Not Applicable
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients who will be administered Remithem® according to the recommendations provided in the product leaflet (Prescribing Information) and local recommendations. 2.Subject scheduled for a therapeutic and diagnostic surgical procedure requiring general anesthesia with Remifentanil as per Prescribing Information for the following indications •As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. •For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. •As an analgesic component of monitored anesthesia care in adult patients. 3.Subjects who provide written informed consent/Assent to abide by the study requirements.
Exclusion criteria
Exclusion criteria: 1.Subjects having the absolute contraindication of the use of Remifentanil include previous anaphylaxis/allergy to Remifentanil or fentanyl analogues or any other component of Remifentanil. Remifentanil is contraindicated for use as the sole agent for induction of anaesthesia. 2.Subjects on regular oral benzodiazepine drugs. 3.Subjects suffering from known organic neurological disorders, psychiatric illnesses with or without treatment and having an ongoing history of alcohol and drug abuse (since past 1 month). 4.Subjects with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 5.Subjects treated with ACE inhibitors and Angiotensin II receptor blockers (ARBs) within 24 hours before the procedure. (Subject can be switched to Calcium channel blockers or Beta blockers if required) 6.Subjects receiving Gabapentin and Pregabalin. 7.Pregnant and lactating females. 8.Subjects simultaneously participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| subjects with any treatment emergent adverse event (TEAEs) during the study period that is from baseline to End of the studyTimepoint: Screening and Baseline(Day 1), End of the Study(Day 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjects with any serious adverse event till End of Study (EOS) 2. Use of rescue analgesia during Surgery 3. Use of vasopressors during surgeryTimepoint: Baseline(Day 1) to End of the Study(Day 2) | — |
Countries
India
Contacts
Public ContactDr Balaji More
Themis Medicare Limited
Outcome results
None listed