CTRI/2024/11/076662已完成Unknown
A Prospective, Multi-centre, Open Label, Single-Arm, Non-interventional Observational Focused Pharmacovigilance Study to assess the safety of Remithem® in Indian patients.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- subjects with any treatment emergent adverse event (TEAEs) during the study period that is from baseline to End of the study
研究概览
简要总结
As this is a Non-interventional PMS study, all treatment and monitoring of the patients will be done at the discretion of the treating physician (investigator) as part of routine practice. Patients who agree to give informed consent (for data sharing)/assent will be enrolled. The dosage regimen will be decided by their anesthetist as recommended in the Package Insert for Remithem® (Remifentanil).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •â€¢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.
- •â€¢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.
排除标准
- •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.
结局指标
主要结局
subjects with any treatment emergent adverse event (TEAEs) during the study period that is from baseline to End of the study
时间窗: Screening and Baseline(Day 1), End of the Study(Day 2)
次要结局
- 1. Subjects with any serious adverse event till End of Study (EOS)(2. Use of rescue analgesia during Surgery)
研究者
Dr Balaji More
Themis Medicare Limited
研究点 (5)
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