跳至主要内容
临床试验/CTRI/2025/07/091912
CTRI/2025/07/091912尚未招募不适用

The Impact of Desflurane Switch at the Conclusion of Sevoflurane Based General Anaesthesia on Patient Emergence and Recovery: A Randomized Controlled Trial

Dr Maria Clifson1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月9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
90
试验地点
1
主要终点
To compare the eye opening time (the time when inhalational anaesthetic is stopped at the end of surgery till the patients first opened their eyes on verbal instruction) between sevoflurane and sevoflurane switched to desflurane

研究概览

简要总结

Patients posted for surgeries requiring general anaesthesia lasting more than 2 hours with endotracheal intubation belonging to the age group of 18-65 years are selected for this study and will be divided into two separate groups, group A and group B consisting of 45 participants each.

The patient will be preoxygenated with a face mask, using 100% oxygen for 3 min followed by intravenous (IV) fentanyl (2 mcg/kg) and propofol (2 mg/kg) for anaesthesia induction. After the loss of consciousness, IV rocuronium (1 mg/kg) will be administered for attaining adequate muscle relaxation. Direct laryngoscopy and endotracheal intubation will be performed by an experienced anaesthesiologist using an appropriately sized endotracheal tube after 1 minute of rocuronium administration.  General anaesthesia is maintained with oxygen, air and sevoflurane to ensure a BIS level of 40–60. Adequate muscle relaxation is ensured during surgery using bolus doses of rocuronium by observing the TOF count.

In both groups, sevoflurane is used intraoperatively as an inhalation anaesthetic to maintain adequate depth of anaesthesia. Patients in Group-A will receive sevoflurane until the end of surgery, while those in Group B will be switched to desflurane 30 minutes before the end of surgery.

At the end of the surgery, residual neuromuscular blockade will be reversed using IV sugammadex (2-4mg/kg) after assessing TOF count.

The eye-opening time will be measured at 10-s intervals from the point when sevoflurane or desflurane is stopped at the end of the surgery until the patient first open their eyes after verbal instructions from the anaesthesiologist. BIS at the time of eye opening is recorded. The time to removal of endotracheal tube and the time to reach BIS 80 after stopping sevoflurane and desflurane are also noted.

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 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists 1 and 2 patients undergoing elective surgeries lasting more than 2 hours under general anesthesia.

排除标准

  • Patient refusal, Allergy to study drugs, Parturient, BMI more than 30, History or family history of malignant hyperthermia.

结局指标

主要结局

To compare the eye opening time (the time when inhalational anaesthetic is stopped at the end of surgery till the patients first opened their eyes on verbal instruction) between sevoflurane and sevoflurane switched to desflurane

时间窗: 18 months

次要结局

  • To compare the time to reach Bispectral Index 80 after discontinuing the inhalational anaesthetic between sevoflurane and sevoflurane switched to desflurane(18 months)
  • To compare the time to endotracheal extubation (the time between stopping administration of inhalational anaesthetic to endotracheal tube removal after sufficient recovery) between sevoflurane and sevoflurane switched to desflurane(18 months)

研究者

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

Dr Maria Clifson

MOSC Medical College Hospital, Kolenchery

研究点 (1)

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