Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric Surgery

• Status: Completed
• Trial end date: 2019-12-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Nitin Sethi
• Treatments: Anesthetics; Desflurane; Isoflurane; Propofol

Criteria

Inclusion Criteria:

• Patients of age 18-65 years

• BMI > 35 kg/m2

• Either sex

• ASA physical status II & III

• Undergoing laparoscopic/ robotic bariatric surgery

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

• Pulmonary dysfunction (obstructive/restrictive lung disease)

• Acute/chronic drug dependence/substance abuse

• Requirement of postoperative ventilation

• Refusal to informed consent