Effect of the Use of Atracurium With or Without Reversal Agent on Haemodynamic Parameters During Extubation: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The goal of this clinical trial is to to observe the haemodynamic parameters including Heart Rate Blood pressure Respiratory rate and Oxygen Saturation with or without giving reversal agent on extubation in patients receiving atracurium on induction , it will also observe post operative residual paralysis respiratory depression and airway reflexes in the post anaesthesia care unit Researchers will compare neostigmine which is the reversal agent and the placebo drug by giving it at the end on surgery before extubation to observe haemodynamic parameters The main questions it aims to answer are Will participants have a stable haemodymaics if no reversal ( neostigmine ) is used during extubation Will it provide a safe extubation and no complications post operatively Participants will be given Either neostigmine or placebo drug at the end of surgery before extubation Will be obseved and monitored for two hours postoperatively in the post anaesthesia care unit Will be monitored for post operative complications like respiratory depression or residual paralysis
.
详细描述
Objective
To observe the haemodynamic parameters including Heart Rate Blood pressure Respiratory rate and Oxygen Saturation with or without giving reversal agent on extubation in patients receiving atracurium on induction , and secondary objective was to observe post operative residual paralysis respiratory depression and cough and gag reflex Study design : Controlled , randomised , and triple Blind trial . Place and duration of study: Dr Ziauddin Hospital Clifton Karachi , from March to June 2025.
Methodology : This was a triple blind study . A total of 100 patients were randomly assigned by the CTU to two groups , the placebo group ( Group A ) and the neoglycopyrolate group (Group B) based on computer generated allocation. At the end of the surgery, patients in Group A were administered IV normal saline and Group B were administered neoglycopyrolate 50 mcg/kg . The primary outcome was to observe heart rate , blood pressure, oxygen saturation and respiratory rate after giving the drug , before extubation , at extubation and at 1mins, 5mins, 10mins, 20mins, and 2h thereafter, while the secondary outcome was to observe post operative airway reflexes and residual paralysis in the post anaesthesia care unit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American society of anaesthesiology class 1 and 2
- •Surgeries lasting for 60 mins
- •.Surgeries requiring general anaesthesia and tracheal intubation and single intubation dose of atracurium
排除标准
- •American society of anaesthesiology class 3 and above
- •Any previous reaction to atracurium
- •Active asthma
- •Severe pulmonary cardiac kindney and liver disease
研究组 & 干预措施
Neostigmine group ( Group B )
This group will reeive neostigmine ( reversal agent ) at the end of surgery before extubation and then haemodynamic parameters will be observed
干预措施: neostigmine (reversal agent) (Drug)
normal saline group ( Group A )
This group will receive normal saline ( no reversal ) at the end of surgery before extubation and then haemodynamic parameters will be observed
干预措施: Placebo drug ( normal saline ) (Drug)
结局指标
主要结局
Heart rate
时间窗: From the time of extubation till discharge from post anaesthesia care unit
To observe Heart rate, via pulse oximeter and ECG
Blood Pressure
时间窗: From the time of extubation till discharge from post anaesthesia care unit
to observe Blood Pressure via Sphygmomanometer
Respiratory Rate
时间窗: From the time of extubation till discharge from post anaesthesia care unit
to observe respiratory rate via capnometer
Oxygen Saturation
时间窗: From the time of extubation till discharge from post anaesthesia care unit
to observe oxygen saturation via pulse oximeter
次要结局
- Airway reflexes(From the time of extubation till discharge from post anaesthesia care unit)
- Residual paralysis(From the time of extubation till discharge from post anaesthesia care unit)
研究者
Fariha Ahmed
Resident anaesthesiology R4
Ziauddin University