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Incidence of Intraoperative Awareness in Indian Patient Population

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ClinicalTrials.gov Identifier: NCT03571945
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

Brief Summary:
The profiling of bi-spectral index (BIS) monitored facilitation of general anesthesia (GA), including, anesthesia induction and maintenance of GA depth state, emergence characteristics, and postoperative recovery parameters, is now extensively available. However, majority of the data supporting the use of BIS have emanated from western Caucasian patient population. Though research on BIS monitoring have also emerged from Asian subcontinent, the data generated, at the best, is too scattered, random, and non-homogenous to reflect onto how BIS guidance fares in Asians on a population basis. We aim to undertake a multi-centric prospective cohort trial in Asian patient population to analyze as to whether BIS guidance toes the profiling and the evidence in Caucasians.

Condition or disease Intervention/treatment Phase
Intraoperative Awareness Device: Bi-spectral Index (BIS QUATRO REF #186-0106) Device: End tidal anaesthesia gas concentration (ETAG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2000- patients aged 18-65 years scheduled for elective surgery under general anaesthesia will be randomly allocated to one of the following two groups:

Group I [BIS Guided Group, n=1000]: GA will be monitored and controlled with Bi-spectral index (BIS).

Group II [ETAG Guided Group, n=1000]: GA will be monitored and controlled with end-tidal anaesthesia gas concentration (ETAG).

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The attending anaesthesiologist will not be blinded to the method of administering GA (BIS or ETAG guided) and recovery immediately after extubation inside the OR. However, the postoperative evaluation of intraoperative awareness and patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
Primary Purpose: Prevention
Official Title: Impact of Bi-spectral Index Guided Inhalation Anaesthesia on the Incidence of Intraoperative Awareness in Indian Patient Population: A Prospective, Randomised, Multi-Centric Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : August 2025

Arm Intervention/treatment
Active Comparator: BIS Guided Group
GA will be monitored and controlled with Bi-spectral index (BIS) monitoring.The anaesthesiologist will be blinded to ETAG and MAC readings.
Device: Bi-spectral Index (BIS QUATRO REF #186-0106)
GA will be monitored and controlled with Bi-spectral index (BIS).

Active Comparator: ETAG Guided Group
GA will be monitored and controlled with end-tidal anaesthesia gas (ETAG) monitoring.The anaesthesiologist will be blinded to the BIS readings.
Device: End tidal anaesthesia gas concentration (ETAG)
GA will be monitored and controlled with end-tidal anaesthesia gas concentration




Primary Outcome Measures :
  1. Incidence of intraoperative awareness [ Time Frame: From end of anaesthesia till 30-days postoperatively ]
    Will be assessed using Modified Brice Interview and Michigan awareness classification instrument


Secondary Outcome Measures :
  1. Intraoperative Bi-spectral index (BIS) score [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively ]
    BIS values will be recorded from the patient monitor

  2. Intraoperative End-tidal anaesthesia gas (ETAG) concentration [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively ]
    ETAG concentration will be recorded from the patient monitor

  3. Intraoperative minimum alveolar concentration (MAC) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively ]
    MAC will be recorded from the patient monitor

  4. Recovery from anaesthesia [ 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

  5. Recovery from anaesthesia [ Time Frame: From end of anaesthesia till 20-minutes postoperatively ]
    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

  6. Changes in intra-operative heart rate (beats per minute) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 8 hours intra-operatively ]
    Comparison of intra-operative heart rate between both the arms will be done

  7. Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively] ]
    Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done

  8. 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). This scale measures postoperative sedation on a scale of 0 to 5. A score of '0' indicates patient is deeply sedated with no response to any stimuli , whereas a score of 5 indicates that the patient is wide awake.

  9. Postoperative Nausea and Vomiting (PONV) [ Time Frame: From end of anaesthesia till 24-hours postoperatively] ]
    Will be assessed using postoperative nausea and vomiting (PONV) Scale. The scale measures PONV on a scale of 0 to 2. A score of '0' indicates that the patient has no emetic symptoms, whereas a score of '2' indicates that the patient has vomiting.

  10. Postoperative Analgesia [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Will be assessed using 10-point Visual Analogue Scale (VAS) Score which measures pain on a scale of 0 to 10. A score of '0' indicates that the patient is free of pain whereas a score of '10' indicates that patient has severe pain.



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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:

  • Male or female gender
  • Aged 18-65 yrs.
  • ASA Physical Status I/II
  • General Anaesthesia
  • Elective Surgery
  • Surgery duration > 30-minutes
  • Consenting for follow-up

Exclusion Criteria:

  • Uncompensated systemic co-morbidity
  • Cardiac and Neurosurgical procedures
  • Head & Neck surgery
  • Obstetric surgery
  • Emergency surgery
  • Anticipated difficult airway
  • H/O brain injury, EEG abnormality
  • Neuropsychiatry disorders
  • Substance abuse (opioids, alcohol, recreational drugs, benzodiazepine)
  • Pacemakers & Electronic implants
  • Obesity (BMI>30kg/m2)
  • Adhesive allergy

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): NCT03571945


Contacts
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Contact: Amitabh Dutta, MD,PGDHR +911142252523 duttaamiatbh@yahoo.co.in
Contact: Nitin Sethi, DNB +919717494498 nitinsethi77@yahoo.co.in

Locations
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India
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Amitabh Dutta, MD, PGDHR    +911142252523    duttaamiatbh@yahoo.co.in   
Contact: Nitin Sethi, DNB    +919717494498    nitinsethi77@yahoo.co.in   
Sub-Investigator: Anil K Jain, MD         
Sub-Investigator: Bhuwan C Panday, MD         
Sub-Investigator: Prabhat Choudhary, MD         
Sub-Investigator: Manish Gupta, MD         
Sub-Investigator: Savitar Malhotra, MD         
Sub-Investigator: Shvet Mahajan, DA, DNB         
Prof. L Parthasarathy Recruiting
Chennai, Tamil Nadu, India, 600002
Contact: L Parthasarathy, DA, MD    00919840049531    drlpsarathy@gmail.com   
Post Graduate Institute For Medical Education & Research Not yet recruiting
Chandigarh, India
Contact: Goverdhan D Puri, MD, PhD       gdpuri007@hotmail.com   
Apollo Gleneagles Hospital Recruiting
Kolkata, India, 700054
Contact: Saikat Sengupta, MD       saikatsg@gmail.com   
P D Hinduja Hospital & Medical Research Centre Recruiting
Mumbai, India
Contact: Ratan Chelani       rare.chels@gmail.com   
Sponsors and Collaborators
Sir Ganga Ram Hospital
Investigators
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Study Chair: Amitabh Dutta, MD, PhD Sir Ganga Ram Hospital
Study Director: Jayashree Sood, MD,FFRCA Sir Ganga Ram Hospital
Principal Investigator: Nitin Sethi, DNB Sir Ganga Ram Hospital

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Responsible Party: Dr Nitin Sethi, Consultant & Associate Professor, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03571945    
Other Study ID Numbers: EC/09/17/1253
First Posted: June 28, 2018    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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Intraoperative Awareness
Intraoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs