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

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ClinicalTrials.gov Identifier: NCT03099616
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

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.

Condition or disease Intervention/treatment Phase
Anesthesia; Bariatric Surgery Drug: Propofol Drug: Desflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Obese Patients Undergoing Bariatric Surgery: A Comparative Randomized Analysis of Recovery Profile
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : December 2, 2019
Actual Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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
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.




Primary Outcome Measures :
  1. Early Recovery [ Time Frame: From end of anaesthesia till 20-minutes postoperatively ]
    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

  2. Early Recovery [ Time Frame: From end of anaesthesia till 30-minutes postoperatively ]
    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

  3. Early recovery [ Time Frame: 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

  4. Intermediate recovery [ Time Frame: From end of anaesthesia till 180-minutes postoperatively ]
    Time taken to achieve a modified Aldrete score of 9 or 10


Secondary Outcome Measures :
  1. Changes in intra-operative heart rate (beats per minute) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intra-operatively ]
    Comparison of intra-operative heart rate between both the arms will be done

  2. Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done

  3. Postoperative Sedation [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Will be assessed using Modified Observer's assessment of alertness/sedation scale (OASS)

  4. Postoperative Nausea and Vomiting [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Will be assessed using PONV Scale

  5. Postoperative Analgeisa [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Will be assessed using 10-point Visual Analogue Scale (VAS) Score

  6. Patient Satisfaction [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Will be assessed using a 10-point numeric rating scale

  7. Anesthesia Depth Consistency [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 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) and Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099616


Locations
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India
Sir Ganga Ram Hospital
New Delhi, Delhi, India, 110060
Sponsors and Collaborators
Dr Nitin Sethi
Investigators
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Study Chair: Goverdhan D Puri, MD, PhD Post Graduate Institute of Medical Education & Research, Chandigarh, India
Study Director: Jayashree Sood, MD,FFRCA Sir Ganga Ram Hospital, New Delhi, INDIA
Principal Investigator: Amitabh Dutta, MD Sir Ganga Ram Hospital, New Delhi, INDIA
Principal Investigator: Nitin Sethi, DNB Sir Ganga Ram Hospital, New Delhi, INDIA
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Responsible Party: Dr Nitin Sethi, Doctor & Associate Professor, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03099616    
Other Study ID Numbers: EC/01/17/1105
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Nitin Sethi, Sir Ganga Ram Hospital:
propofol
CLADS
Desflurane
Obesity
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Propofol
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation