CTRI/2021/01/030800已完成3 期
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 - REM-01
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •3. Subjects who provide a written informed
- •consent to abide by the study requirements.
排除标准
- •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.
研究者
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