Impact of Bi-spectral Index Guided Inhalation Anaesthesia on the Incidence of Intraoperative Awareness in Indian Patient Population: A Prospective, Randomised, Multi-Centric Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- Incidence of intraoperative awareness
研究概览
简要总结
The profiling of bi-spectral index (BIS) monitored facilitation of general anesthesia (GA), including, anesthesia induction and maintenance of GA depth state, emergence characteristics, and postoperative recovery parameters, is now extensively available. However, majority of the data supporting the use of BIS have emanated from western Caucasian patient population. Though research on BIS monitoring have also emerged from Asian subcontinent, the data generated, at the best, is too scattered, random, and non-homogenous to reflect onto how BIS guidance fares in Asians on a population basis. We aim to undertake a multi-centric prospective cohort trial in Asian patient population to analyze as to whether BIS guidance toes the profiling and the evidence in Caucasians.
详细描述
After Institutional Ethics Committee approval and informed written patient consent, 2000 patients justifying inclusion and exclusion criteria ( will be included in this National, multi-centric, prospective, randomised, double-blind (patients, analyst), 2- arm trial.
All the patients scheduled for elective surgery under general anaesthesia will be randomly (simple computer generated random number table) allocated to one of the following two groups:
Group I [BIS Guided Group, n=1000]: GA will be monitored and controlled with Bi-spectral index (BIS).
Group II [ETAG Guided Group, n=1000]: GA will be monitored and controlled with end-tidal anaesthesia gas concentration (ETAG).
Sample Size Estimation To detect a difference in incidence of awareness of 0.04 % (a rate based on Mashour et al, Anesthesiology 2012) between the ETAG and BIS-guided group a total of 1800 patients will be required at a power of 80% with a type-II error 0f 0.5. To compensate for possible drop outs 10% additional patients will be recruited for the study. Therefore, the total sample size will include 2000 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The attending anaesthesiologist will not be blinded to the method of administering GA (BIS or ETAG guided) and recovery immediately after extubation inside the OR. However, the postoperative evaluation of intraoperative awareness and patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female gender
- •Aged 18-65 yrs.
- •ASA Physical Status I/II
- •General Anaesthesia
- •Elective Surgery
- •Surgery duration > 30-minutes
- •Consenting for follow-up
排除标准
- •Uncompensated systemic co-morbidity
- •Cardiac and Neurosurgical procedures
- •Head & Neck surgery
- •Obstetric surgery
- •Emergency surgery
- •Anticipated difficult airway
- •H/O brain injury, EEG abnormality
- •Neuropsychiatry disorders
- •Substance abuse (opioids, alcohol, recreational drugs, benzodiazepine)
- •Pacemakers & Electronic implants
- •Obesity (BMI>30kg/m2)
- •Adhesive allergy
结局指标
主要结局
Incidence of intraoperative awareness
时间窗: From end of anaesthesia till 30-days postoperatively
Will be assessed using Modified Brice Interview and Michigan awareness classification instrument
次要结局
- Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)(From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively])
- Intraoperative minimum alveolar concentration (MAC)(From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively)
- Postoperative Nausea and Vomiting (PONV)(From end of anaesthesia till 24-hours postoperatively])
- Postoperative Analgesia(From end of anaesthesia till 24-hours postoperatively)
- Intraoperative End-tidal anaesthesia gas (ETAG) concentration(From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively)
- Changes in intra-operative heart rate (beats per minute)(From beginning of anesthesia (0-hours, baseline) till 8 hours intra-operatively)
- Recovery from anaesthesia(From end of anaesthesia till 20-minutes postoperatively)
- Postoperative Sedation(From end of anaesthesia till 24-hours postoperatively])
- Intraoperative Bi-spectral index (BIS) score(From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively)
研究者
Nitin Sethi, DNB
Consultant & Associate Professor
Sir Ganga Ram Hospital