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

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.

Conditions

• Anesthesia; Bariatric Surgery

Interventions

DRUG

Propofol

Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.

DRUG

Desflurane

Desflurane delivery will be controlled using a agent specific vaporiser. The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients.

Sponsors & Collaborators

• Dr Nitin Sethi

  lead OTHER

Principal Investigators

• Goverdhan D Puri, MD, PhD · Post Graduate Institute of Medical Education & Research, Chandigarh, India

• Jayashree Sood, MD,FFRCA · Sir Ganga Ram Hospital, New Delhi, INDIA

• Amitabh Dutta, MD · Sir Ganga Ram Hospital, New Delhi, INDIA

• Nitin Sethi, DNB · Sir Ganga Ram Hospital, New Delhi, INDIA

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-04

Primary Completion

2019-12-02

Completion

2019-12-02

Countries

• India

Study Locations