"A Comparative Study of Sugammadex with Neostigmine on Efficacy and Safety in Reversing Vecuronium Induced Neuromuscular Blockade in Adult Patients"
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare recovery from vecuronium-induced neuromuscular blockade with sugammadex to that with neostigmine/glycopyrrolate. (fast recover, patient responsiveness)
研究概览
简要总结
To study the efficacy and safety of Sugammadex versus Neostigmine/glycopyrrolate in reversing vecuronium induced neuromuscular blockade in adult Indian population. To compare recovery from vecuronium-induced neuromuscular blockade with sugammadex to that with neostigmine/glycopyrrolate. (fast recover, patient responsiveness)
also to see and evaluate the side effects of a single dose of sugammadex 2 mg/kg to neostigmine 0.05mg/kg (plus glycopyrrolate) in adult patients, Event of residual paralysis,Total time spend in Operating room and PACU after extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and III Subjects born in India, have never emigrated out of India and have an Indian home address.
- •Patients undergoing elective surgical procedures under general anaesthesia Hemodynamically stable patients with all routine investigations within the normal limits.
- •Patients who give informed written consent and are willing to be a part of the study.
排除标准
- •Age less than 18yrs and more than 65yrs ASA grading more than III Patients with anatomical malformations expected to lead to difficult tracheal intubation Known or suspected neuromuscular disorders affecting NMB Significant renal/hepatic dysfunction, (family) history of malignant hyperthermia, Allergy to general anaesthesia medications,contraindication to study drugs Medication known to interfere with NMBAs (such as anticonvulsants, aminoglycosides, and magnesium-containing medications) Patients Not Giving Consent.
结局指标
主要结局
To compare recovery from vecuronium-induced neuromuscular blockade with sugammadex to that with neostigmine/glycopyrrolate. (fast recover, patient responsiveness)
时间窗: 6 months
次要结局
- To evaluate the side effects of a single dose of sugammadex 2 mg/kg to neostigmine 0.05mg/kg (plus glycopyrrolate) in adult patients
研究者
Dr Jayalakshmi Mohan
DR D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI , PUNE