Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Obese Patients Undergoing Bariatric Surgery: A Comparative Randomized Analysis of Recovery Profile
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Early Recovery
研究概览
简要总结
Complete recovery from anaesthesia is absolutely desirable in the obese patients to avoid postoperative airway, oxygen ventilation or sleep apnea related complications. Over the years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of anaesthesia in obese patients for its efficient elimination profile and ability to facilitate early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen. However, it is a lipid soluble drug and there are concerns that it may accumulate in obese patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to result in a prolonged duration of action and consequently, delayed emergence from anaesthesia and a protracted recovery time. A recent advance in the delivery of Propofol to the patient is the development of computer-controlled anesthesia delivery systems. These devices deliver Propofol based on feedback from patient's frontal cortex electrical activity as determined by monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has shown that Propofol and maintain depth of anesthesia with far more precision as compared to manual/simple infusion administration. This, in turn, holds promise that recovery from Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system (CLADS), which has been extensively evaluated in patients belonging to different surgical settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown significant improvement in recovery outcome.The performance of CLADS has not yet been evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing bariatric surgery, automated delivery of Propofol using CLADS would allow precision control of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We plan to conduct a randomised controlled investigation to compare patient recovery profile following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.
详细描述
After Institutional Ethics Committee approval and written informed consent, forty-participants (20 per group) aged 18-65 years, ASA physical status I/III, BMI >35-kg/m2, of either sex, and undergoing laparoscopic/robotic bariatric surgery (sleeve gastrectomy or gastric bypass) will be included in this single center (Sir Ganga Ram Hospital, New Delhi-110060, India) prospective, double-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=20]: Anaesthesia will be induced and maintained with Propofol administered using the automated CLADS.
Group-2 [Desflurane Group, n=20]: Anaesthesia will be induced with Propofol administered using the automated CLADS and will be maintained with Desflurane.
Sample-size Estimation
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
- •Patients of age 18-65 years
- •BMI > 35 kg/m2
- •Either sex
- •ASA physical status II & III
- •Undergoing laparoscopic/ robotic bariatric surgery
排除标准
- •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
- •Pulmonary dysfunction (obstructive/restrictive lung disease)
- •Acute/chronic drug dependence/substance abuse
- •Requirement of postoperative ventilation
- •Refusal to informed consent
研究组 & 干预措施
CLADS group
Anesthesia will be induced with Propofol administered by CLADSwhich will be set to deliver Propofol according to lean body weight (LBW). A BIS-value of 50 will be used as the target for induction of anesthesia. Thereafter anaesthesia maintenance will be done with Propofol, with the dosing based on adjusted body weight (ABW), and administration controlled with CLADS tuned to consistent anaesthetic depth (BIS-50) feedback from the patients.
干预措施: Propofol (Drug)
Desflurane group
Anesthesia will be induced with Propofol administered by CLADSwhich will be set to deliver Propofol according to lean body weight (LBW). A BIS-value of 50 will be used as the target for induction of anesthesia.Thereafter anaesthesia maintenance will be done with desflurane using an agent specific vaporiser, whose dial concentration will be adjusted to maintain a BIS of 50-55 in all the patients
干预措施: Propofol (Drug)
Desflurane group
Anesthesia will be induced with Propofol administered by CLADSwhich will be set to deliver Propofol according to lean body weight (LBW). A BIS-value of 50 will be used as the target for induction of anesthesia.Thereafter anaesthesia maintenance will be done with desflurane using an agent specific vaporiser, whose dial concentration will be adjusted to maintain a BIS of 50-55 in all the patients
干预措施: Desflurane (Drug)
结局指标
主要结局
Early Recovery
时间窗: From end of anaesthesia till 30-minutes postoperatively
Time taken for tracheal extubation after discontinuation of anaesthesia will be noted
Intermediate recovery
时间窗: From end of anaesthesia till 180-minutes postoperatively
Time taken to achieve a modified Aldrete score of 9 or 10
Early recovery
时间窗: From end of anaesthesia till 30-minutes postoperatively
Ability of the patient to comprehend instructions for shifting himself/herself from the OR table to the transport bed will be assessed using a 4-point scale
次要结局
- Changes in intra-operative heart rate (beats per minute)(From beginning of anesthesia (0-hours, baseline) till 6 hours intra-operatively)
- Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)(From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively)
- Postoperative Nausea and Vomiting(From end of anaesthesia till 24-hours postoperatively)
- Postoperative Analgeisa(From end of anaesthesia till 24-hours postoperatively)
- Postoperative Sedation(From end of anaesthesia till 24-hours postoperatively)
- Patient Satisfaction(From end of anaesthesia till 24-hours postoperatively)
- Anesthesia Depth Consistency(From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively])
研究者
Dr Nitin Sethi
Doctor & Associate Professor
Sir Ganga Ram Hospital
