Comparison of Sugammadex and Neostigmine combination versus Sugammadex for reversal of vecuronium induced neuromuscular blockade in overweight patients- Randomised Control Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare effectiveness of sugammadex with neostigmine and sugammadex for reversal of vecuronium induced neuromuscular blockade in patients with BMI more than 25 kg per metre square by using 90 percentage TOF ratio
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy and safety of a half-dose sugammadex combined with neostigmine versus full-dose sugammadex alone for reversing vecuronium-induced deep neuromuscular blockade in patients with BMI > 25kg/m² undergoing elective surgeries under general anesthesia. The study addresses both clinical outcomes and economic considerations, given the high cost and potential adverse effects of sugammadex at full doses. The primary endpoint is the time to disappearance of fade in Double Burst Stimulation (DBS), with secondary endpoints including adverse effects, extubation time, cost-effectiveness, and hemodynamic changes. Ninety patients will be enrolled in a double-blinded, randomized design at a tertiary care hospital. This study hopes to establish a safer, faster, and more cost-effective reversal strategy in overweight and obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •BMI more than 25 kg per metre square 2) Undergoing elective surgery and requiring the use of muscle relaxants throughout the surgery.
- •ASA physical status 1 to 3.
排除标准
- •Presence of renal dysfunction defined as creatinine more than 1.2 mg per dl 2) Known hepatic disease 3) Obstructive sleep apnea 4) Allergic to general anaesthesia drugs 5) History of substance abuse.
- •Altered mental status.
- •Patients receiving medications known to interfere with neuromuscular transmission or having neuromuscular disease.
结局指标
主要结局
To compare effectiveness of sugammadex with neostigmine and sugammadex for reversal of vecuronium induced neuromuscular blockade in patients with BMI more than 25 kg per metre square by using 90 percentage TOF ratio
时间窗: 1 min, 5mins, 10mins, 15 mins,30 mins
次要结局
- incidence of adverse events less in combined half dose of sugammadex & neostigmine & to find which is cost effective(within 24 hours post surgery)
研究者
Dr Prasanna Vadhanan
Vinayaka Missions Medical College and Hospital, Karaikal