跳至主要内容
临床试验/CTRI/2023/02/049969
CTRI/2023/02/049969已完成不适用

Effect of Sugammadex versus Neostigmine Reversal on Lung Aeration Score after Operative Fixation of Cervical Spine:A Prospective, Double Blinded, Randomised Control Trial

AIIMS1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
AIIMS
入组人数
70
试验地点
1
主要终点
To compare the lung aeration score at 24 hours post operatively.

研究概览

简要总结

Post operative pulmonary complications (POPC) are one of the leading contributors of prolonged hospital stay. The incidence of respiratory complications in patients with cervical spine injury (CSI) is well reported and the pathophysiology behind these complications after CSI is complex and multifactorial. Surgical decompression is often recommended for both traumatic and degenerative cervical spine pathologies currently. The altered lung mechanics during corrective surgery further contributes to the development of pulmonary morbidities. Residual neuromuscular blockade after surgery is one common culprit behind the development of pulmonary complications subsequently. Sugammadex, a gamma-cyclodextrin compound has shown promising results in reducing the incidence of POPC in different subgroup of patients. It has been postulated that, due to the unique mechanism, sugammadex is able to reverse the effect of steroidal non-depolarizing neuromuscular blocking agents more efficiently as compared to traditional neostigmine reversal. There is no available study where sugammadex was used in CSI patients.

Lung ultrasound is an easy and effective modality to detect several underlying respiratory pathologies. Depending on the number of B-lines found in specific areas during sonography, a quantitative scoring system have been postulated which have been widely used in various settings for prediction of weaning from mechanical ventilation, for ventilatory strategy intraoperatively as well as in ARDS patients, for perioperative assessment of the lung aeration etc. Lung aeration score has been successfully used to predict POPCs after major abdominal surgeries.  In this prospective, double-blind randomized control trial, we hypothesize that Sugammadex reversal will result in a lower i.e., better lung aeration score 24 hrs after surgery as compared to the neostigmine group. We have, therefore, planned this study to compare the effect of sugammadex to neostigmine on the lung aeration score after surgical fixation of CSI.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA I-III physical status patients 2.Who have consented to participate in the study 3.Age- 18-65 years.

排除标准

  • 1.Chronic kidney disease 2.Chronic liver disease 3.Allergy to study drugs 4.Patients with previously diagnosed lung pathologies- COPD, Asthma, pneumonia or any other known lung pathology.
  • 5.Obese patients 6.Patients with previous thoracic surgery 7.Chest wall deformity 8.Recent surgery under GA in last 30 days 9.Patients with associated chest injury 10.Traumatic brain injury.

结局指标

主要结局

To compare the lung aeration score at 24 hours post operatively.

时间窗: Just before the start of the surgery and 24 hours after the end of the surgery

次要结局

  • 1.Length of ICU stay(2.Length of hospital stay)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验