Comparison of Sugammadex and Neostigmine on the reversal of vecuronium induced neuromuscular blockade in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia- a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Time taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more.
研究概览
简要总结
This randomized, double blinded clinical trial will be conducted to compare sugammadex and neostigmine for the reversal of vecuronium induced neuromuscular blockade in 36 patients of ASA I or II aged 18 to 60 years, of both sexes, of Manipuri Ethnicity undergoing elective laparoscopic cholecystectomy under general anaesthesia in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur.
The patients will be randomly divided into two groups (Group A and Group B) of 18 participants each. Group A patients will receive 10 ml of Inj. Sugammadex 2mg/kg and Group B patients will receive 10 ml of Inj. Neostigmine 50mcg/kg (to a maximum of 5mg) plus glycopyrrolate 10mcg/kg when four twitches to train of four stimulation appear. The time taken from the start of administration of the study drugs at appearance of fourth twitch of train of four stimulation to its normalised ratio of 0.9 and time taken to attain 5 sec head lift from the administration of the study drugs will be compared for the two groups. Additionally, hemodynamic parameters and side effects, if any, will be assessed.
All the findings and observations made during the entire study will be tabulated, graphically depicted wherever possible, statistically analyzed and inference will be drawn to evaluate and compare the two drugs with their clinical advantages and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex-male or female
- •Patients of age group 18 to 60 years of Manipuri ethnicity undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia.
- •Patients of American Society of Anesthesiologists (ASA) physical status grade I or II.
排除标准
- •Patients not willing to participate
- •Patients with known allergy to any of the study drugs
- •Patients with known neuromuscular disease.
- •Patients with pre-existing respiratory, cardiovascular, hepatic or renal dysfunction.
- •Patients with suspected malignant hyperthermia
- •Patient who had joined in any studies in the past one month.
结局指标
主要结局
1. Time taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more.
时间窗: 1. Time (mins) taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more( single time point) | 2. Time (mins) to 5 secs head lift from the start of administration of the study drugs( single time point).
2. Time to 5 secs head lift from the time of administration of the study drugs.
时间窗: 1. Time (mins) taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more( single time point) | 2. Time (mins) to 5 secs head lift from the start of administration of the study drugs( single time point).
次要结局
- 1. Hemodynamic parameters such as blood pressure(BP) & heart rate (HR).(2. Incidences of train of four normalized ratio of less than 0.9 during the first hour of post-operative period.)
研究者
LALAN SINGAM
Regional Institute of Medical Sciences