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临床试验/CTRI/2025/07/091306
CTRI/2025/07/091306尚未招募不适用

Comparison of recovery characteristics of sugammadex versus neostigmine in the elderly patient undergoing rigid bronchoscopy: A randomised controlled trial

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Extubation time in the elderly patient undergoing rigid bronchoscopy

研究概览

简要总结

All eligible participants will be seen the primary investigator one day prior to surgery and written informed consent will be taken. NPO instructions will be explained to the patient. On the day of surgery, Elderly will receive IV midazolam pre-operatively 0.5 mg/kg if needed or requested, 20-30 minutes before induction. ASA standards monitoring -oxygen saturation probe (SPO2), ECG, NIBP will be attached simultaneously. Intravenous induction will be done by IV fentanyl (1-2 µg/kg) followed by IV Propofol (2-2.5 mg/kg) or Etomidate (0.2-0.6mg/kg) followed by muscle relaxant Rocuronium (0.4-0.6 mg/kg). A rigid bronchoscope with side ventilation port will be used for mechanical ventilation.

Maintenance of anesthesia will be by sevoflurane to achieve approximately 0.8-1 MAC. Fentanyl will be repeated as per clinical requirement in 0.5 µg/kg aliquots. This will be documented. Rocuronium maintenance doses will be guided by neuromuscular monitoring (Target of 0-1 TOF count). Intraoperative outcomes and drug requirements will be measured. At the end of surgery,

  • Group A participants will receive 0.05mg/kg of Neostigmine and 0.01mg/kg glycopyrrolate IV for muscle blockade reversal at the end of surgery when TOF ratio <0.4 or TOF count 2-3.
  • Group B participants will receive 2mg/kg of Sugammadex IV at the end of surgery after achieving 1-2 TOF count, or 4 mg/Kg when no twitch responses to TOF stimulation.

Extubation time is calculated from the time sugammadex or neostigmine is given till TOF>0.9 is achieved in patient for extubation

Haemodynamic and clinical parameters will be measured throughout the surgery and in the PACU. All elderly will be assessed for post pulmonary complication in PACU for 1 hour and in ward till patient is discharged from hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age: more than or equal to 60 years,ASA class I.
  • III, all patients undergoing diagnostic or therapeutic bronchoscopy,patients giving consent for procedure will be considered for the study.

排除标准

  • 1.Patient has already undergone any thoracic surgery in the past
  • Patient with ventilated support
  • Severe cardiac diseases
  • Known previous allergy to any drugs.

结局指标

主要结局

Extubation time in the elderly patient undergoing rigid bronchoscopy

时间窗: At time of extubation of trachea

次要结局

  • To compare perioperative vitals between the groups ,to compare any complications following administration of of Sugammadex and Neostigmine such as hypotension, laryngospasm, apnea, pneumonia, atelectasis etc(and to compare postoperative breath-holding time (BHT) following neuromuscular blockade reversal with Sugammadex versus Neostigmine, measured at 15 and 30 minutes after extubation, in comparison to preoperative BHT)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Paras Khadayat

All india institute of medical sciences- Rishikesh

研究点 (1)

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