Prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate safety and efficacy of Cisatracuruim Besylate versus Atracurium Besylate for neuromuscular blockade in adult patients, undergoing diagnostic or therapeutic surgical procedures.

Themis Medicare Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Inclusion Criteria
•1. Patients of either sex in the age group between 18 to 65 years.
•2. Patients scheduled for elective diagnostic / therapeutic surgical procedure to be completed within 120 minutes with an ASA status ranging from P1 to P4
•3. Subjects who provide a written informed consent to abide by the study requirements.

•1.Patients undergoing emergency surgical procedure / surgical procedure with likely duration for completion 120 minutes.
•2.Patients receiving medication known to interfere with neuromuscular blockers for e.g. : anti-convulsants, amino glycosides or polypeptide antibiotics, magnesium
•3.Patients with anticipated difficult intubation (Mallampati score III and more)
•4.Patients with diseases affecting neuromuscular transmission (myasthenia gravis or myopathies).
•5.Subjects known or suspected to have a (family) history of malignant hyperthermia
•6. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
•7. Patients treated with any other oral / parenteral opioids or benzodiazepines within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period.
•8. Patients suffering from organic neurological disorders, psychiatric illnesses and H/o drug abuse.
•9. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
•10.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
•11. Pregnant and lactating females.
•12. Patients simultaneously participating in another clinical study.

发起方