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临床试验/CTRI/2025/04/083913
CTRI/2025/04/083913尚未招募不适用

Effect of sugammadex versus neostogmine/glycopyrrolate combination on peak expiratory flow rates in adult patients undergoing laparoscopic surgery

Dr Penna Srihitha1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
86
试验地点
1
主要终点
To compare peak expiratory flow rates

研究概览

简要总结

Neuromuscular blocking drugs (NMB), both depolarizing and nondepolarizing are one of the

commonly used drugs in Anaesthesia. They make intubation easy and provide muscle relaxation

during crucial steps in an operation and improve surgical conditions. But their usage may lead to few

complications when the muscle relaxation effect is not adequately reversed after surgery. When NMB

drugs effect is inadequately reversed it may lead to various untoward events like reintubation, upper

airway obstruction, decreased functional residual capacity, pneumonia, atelectasis and increased

duration of stay in the hosipital.

Sugammadex is a modified gamma-cyclodextrin and it is a drug used for reversal of

vecuronium, rocuronium induced neuro muscular blockade. Unlike traditional reversal agents like

neostigmine, whose mechanism of action is inhibiting acetylcholinesterase to increase levels of

acetylcholine at the neuro muscular junction, Sugammadex forms one-to-one complexes with neuro

muscular blocking drugs (vecuronium, rocuronium) and decreases plasma concentration of these

drugs. This mechanism provides rapid and complete reversal of NMB and allows faster recovery of

muscle function and safe emergence from anaesthesia.

Peak expiratory flow rate (PEFR) is the instantaneous velocity of the expiratory flow during

the pulmonary function test, which reflects the respiratory muscle strength and any obstruction in the

airway. It reflects the reduction in pulmonary function which is caused by Residual Neuro muscular

blockade (RNMB).PEFR is a useful tool for assessing post operative pulmonary complications.

In this study All the patients will undergo pre anaesthesia check up (General, physical, Systemic examination) and routine investigations before surgery. The patient will be maintained NPO 8hours for solids and

2hrs for clear fluids. Pre-operative peak expiratory flow rates and global lung ultrasound will be done. On the day of surgery patient is taken into the operation theatre and ASA standard monitoring will be done including Spo2,NIBP, ECG, Heart rate, Temperature, NMT. IV cannulation will be done(18G/20G). All the patients will be preoxygenated and Fentanyl (2mcg/kg), Propofol(1.52mg/kg), vecuronium(0.1mg/kg) will be administered. Patient will be intubated with single lumen endotracheal tube. Anaesthesia will be maintained with Isoflurane (50% oxygen and 50% air mixture). Vecuronium maintenance dose will be given (0.015mg/kg) to maintain TOF count < 2.

Intra operatively total duration of pneumoperitoneum will be noted. For reversal of neuromuscular blockade patients in neostigmine group will receive Neostigmine (50mcg/kg) +glycopyrrolate (10mcg/kg) administered when TOF count will be >4 or Sugammadex (2mg/kg) will be given in group S. Time interval from administration of reversal agent to extubation will be noted. Time to achieve modified Aldrete score >8 will be  noted. Post operative peak expiratory flow rates and global lung ultrasound scores will be noted 30min post extubation.

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

  • ASA 1-3, scheduled for laparoscopic cholecystectomy.

排除标准

  • previously diagnosed respiratory disorders, BMI more than 30 kg/m2, Uncooperative patient, patient for emergency surgery, patients allergic to sugammadex or neostigmine.

结局指标

主要结局

To compare peak expiratory flow rates

时间窗: 30minutes post extubation

次要结局

  • Time to attain TOF more than 0.9
  • Time interval(Administration of reversal agent to extubation)
  • Need for re intubation(Post extubation)
  • Incidence of PPC(post operative)
  • To compare global lung ultrasound scores(30minutes post extubation)
  • Time taken for modified aldrete score to reach more than 8(Post operative)
  • To note total duration of pneumoperitoneum(Intraoperative)

研究者

发起方
Dr Penna Srihitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Penna Srihitha

PGIMER CHANDIGARH

研究点 (1)

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