Evaluation of Automated Delivery of Propofol Using Closed-Loop Anaesthesia Delivery System in Patients Undergoing Thoracic Surgery: A Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anaesthesia depth consistency using BIS scores
研究概览
简要总结
Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers propofol based on patient's frontal cortex electrical activity as determined by bi-spectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration.
By automatically controlling anaesthesia depth consistency they provide time to the anaesthesiologist to focus on other aspects of patient care such as managing intra-operative hemodynamics and ventilation perturbations during major surgeries.
Closed loop anaesthesia delivery system (CLADS) is an indigenously developed continuous automated intravenous infusion system which delivers propofol based on patients EEG profile (BIS) feedback. Although a few studies have already evaluated these automated systems in patients undergoing thoracic surgery, but suffered from significant limitations (small number of patients, not dedicated to thoracic surgery cohort). Currently, there is no data available regarding CLADS performance vis a vis adequacy of GA and haemodynamic profile in patients undergoing thoracic surgery.
We contend that propofol as delivered by CLADS will proffer greater consistency to anaesthesia depth, intra-operative hemodynamic stability, and rapid recovery upon anaesthesia discontinuation than manual means of delivering propofol TIVA. This randomised controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus manually controlled propofol TIVA in patients undergoing thoracic surgery.
详细描述
After Ethics Committee approval and written informed consent, thirty-participants (30 per group) aged 18-65 years, ASA physical status I-III, of either sex, and undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS) will be included in this single centre (Sir Ganga Ram Hospital, New Delhi-110060, India) prospective, single-blinded, two-arm, randomised controlled study.
The patients who qualify inclusion criteria and consent for recruitment will be randomly divided into one of the two groups:
Group-1 [CLADS Group, n=15, Study group]: Anaesthesia will be induced and maintained with propofol administered using the automated CLADS.
Group-2 [Manual Group, n=15, Control group]: Anaesthesia will be induced and maintained with propofol administered using manually controlled infusion pumps titrated to BIS scores.
Sample-size Estimation In a previous multi-centre study, the percentage of time the BIS was within 10 percentage of the target BIS was 81.4 percent in the CLADS group versus 55.34 percent in the manual group. Based on the above, to detect 20 percent difference in the two groups, a sample size of 12 patients per group to provide 90 percent power with a bilateral alpha risk value of 0.05 will be required. We plan to recruit a total of 30 patients to cover up for unanticipated losses after the recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be blinded to the type of anaesthesia intervention.The attending anaesthesiologist will however not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. The postoperative 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
- •ASA physical status I-III
- •undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS)
排除标准
- •Exclusion Criteria:
- •Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)
- •Hepato-renal insufficiency
- •Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
- •Known allergy/hypersensitivity to the study drug
- •Drug dependence/substance abuse
- •Requirement of postoperative ventilation
- •Refusal to informed consent
研究组 & 干预措施
CLADS group
Anaesthesia will be induced and maintained with Propofol administered by CLADS. Its administration rate will be controlled by a feedback loop facilitated by BIS monitoring. A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.
干预措施: Propofol (Drug)
Manual group
Anaesthesia will be induced and maintained with propofol administration by an intravenous infusion pump. Its administration rate will be controlled manually to maintain a target BIS of 50 during induction and maintenance of anaesthesia.
干预措施: Propofol (Drug)
结局指标
主要结局
Anaesthesia depth consistency using BIS scores
时间窗: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.
次要结局
- Propofol maintenance dose (mg/kg/hr)(From 2-minutes intraoperatively till 10-hours intraoperatively)
- Performance Characteristic of propofol anaesthesia delivery system(From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively)
- Change in Intra-operative heart Rate (beats per minute)(From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively)
- Change in Intra-operative systolic , diastolic, and mean (mmHg)(From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively)
- Recovery from anesthesia(From end of anaesthesia till 20-minutes postoperatively])
- Intra-operative awareness(From the end of anaesthesia till 48-hours postoperatively)
- Propofol induction dose (mg)(From start of propofol injection till 2- minutes intraoperatively)
研究者
Dr Nitin Sethi
Associate Professor & Consultant
Sir Ganga Ram Hospital