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

NCT03099616 | Completed Phase 4 DMC

• 1 other identifier: EC/01/17/1105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propofol; CLADS; Desflurane; Obesity

Outcome Measures

Primary Outcomes (4)

• Early Recovery

  Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

  From end of anaesthesia till 20-minutes postoperatively

• Early Recovery

  Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

  From end of anaesthesia till 30-minutes postoperatively

• Early recovery

  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

  From end of anaesthesia till 30-minutes postoperatively

• Intermediate recovery

  Time taken to achieve a modified Aldrete score of 9 or 10

  From end of anaesthesia till 180-minutes postoperatively

Secondary Outcomes (7)

• 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 Sedation

  From end of anaesthesia till 24-hours postoperatively

• Postoperative Nausea and Vomiting

  From end of anaesthesia till 24-hours postoperatively

• Postoperative Analgeisa

  From end of anaesthesia till 24-hours postoperatively

Study Arms (2)

CLADS group

ACTIVE COMPARATOR

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.

Drug: Propofol

Desflurane group

ACTIVE COMPARATOR

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

Drug: Propofol; Drug: Desflurane

Interventions

Propofol DRUG

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.

CLADS group; Desflurane group

Desflurane DRUG

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.

Desflurane group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 18-65 years
• BMI \> 35 kg/m2
• Either sex
• ASA physical status II \& III
• Undergoing laparoscopic/ robotic bariatric surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Nitin Sethi: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

Obesity

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Goverdhan D Puri, MD, PhD

  Post Graduate Institute of Medical Education & Research, Chandigarh, India

  STUDY CHAIR

• Jayashree Sood, MD,FFRCA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY DIRECTOR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor & Associate Professor

Model Details: 40 patients belonging to ASA physical patients status II and III of either sex, scheduled to undergo laparoscopic/robotic bariatric surgery (sleeve gastrectomy, Rouxen- Y gastric bypass) under general anaesthesia. The patients will be randomly allocated by computer generated numbers to one of the following two groups of 20 patients each. 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.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: April 4, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

IN (1)