A randomized control trial comparing recovery profile of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To compare time for eye opening of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems.
研究概览
简要总结
• Study will be conducted after taking approval from Central Scientific Review committee, Institutional Ethical committee and CTRI registration.
• Patients undergoing tympanoplasty will be screened for the study.
• All the eligible patients as per the inclusion and exclusion criteria, will be explained about the nature, purpose and methodology of the study with the help of a participant information sheet and informed consent will be taken.
• It will be explained to the patient that they will be blinded as to which depth of anaesthesia monitor will be applied intra-operatively in their procedure.
• The patient will then be randomly allocated by computer-based program to one of the two groups -
a. GROUP A –Patients in which Depth will be monitored by qCON
b. GROUP B –Patients in which Depth will be monitored by BIS.
• Patients’ details will be filled according to proforma.
• All patients will be kept nil per oral 6 hours prior to surgery.
• Monitors will be attached, and IV line secured with 20 G cannula. Vitals and other parameters to be recorded.
• Anaesthesia plan will be Total Intravenous Anaesthesia with supplemental oxygen using nasal prongs.
• Inj. Midazolam 0.05mg/kg for premedication, Inj. Remifentanil 0.5 mcg/kg/min infusion and Inj. Propofol 2mg/kg for induction. Maintenance will be done with Inj. Propofol 50mcg/kg/min infusion.
• The dose of Propofol infusion will be adjusted intraoperatively every 10 mins guided by BIS/qCON systems, maintaining a score of 40-60. For every increase/decrease in score by 10, propofol infusion will be changed by 10mcg/kg/min respectively. Number of patient movements and Propofol adjustments will be noted.
• Infusions will be stopped at the end of the surgery. Then, the time taken for eye-opening of the patient, from the end of infusions will be noted and the amount of Inj. Propofol used per hour during the surgery will be calculated.
• Once the patient is shifted in Post Anesthesia Care Unit, sedation will be assessed using Ramsay Sedation Scale as follows at 0, 15 and 30 mins post eye opening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •All elective tympanoplasty surgeries under Total Intravenous Anaesthesia lasting between 1.5 to 3 hours 2.Patient categorized under American Society of Anaethesiology Categories I, II and III.
排除标准
- •Patients categorized under American Society of Anaethesiology Categories IV and above.
- •Patients unwilling to sign the written consent.
- •Patients that require mechanical ventilation or do not have a patent airway.
结局指标
主要结局
To compare time for eye opening of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems.
时间窗: After stopping of Infusions. Time at which primary outcome is achieved will be noted down
次要结局
- i. To compare the amount of Propofol required per hour between qCON & BIS guided depth of anaesthesia monitoring systems.(After the stopping of infusions. Immediately after the surgery gets over)
- ii. To evaluate the Ramsay Sedation Score- 0, 15 & 30 mins after the end of infusion & compare them for qCON & BIS guided depth of anaesthesia monitoring systems(0, 15 & 30 mins after the end of infusion)
研究者
Siddhant Sugandhi
Bharati Hospital and Research Centre