Incidence of Intraoperative Awareness in Indian Patient Population

NCT03571945 | Suspended DMC FDA Device

• 1 other identifier: EC/09/17/1253
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Intraoperative Awareness

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative awareness

  Will be assessed using Modified Brice Interview and Michigan awareness classification instrument

  From end of anaesthesia till 30-days postoperatively

Secondary Outcomes (10)

• Intraoperative Bi-spectral index (BIS) score

  From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively

• Intraoperative End-tidal anaesthesia gas (ETAG) concentration

  From beginning of anaesthesia (0-hours, baseline) till 8 hours intraoperatively

• Intraoperative minimum alveolar concentration (MAC)

  From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively

• Recovery from anaesthesia

  From end of anaesthesia till 20-minutes postoperatively

• Recovery from anaesthesia

  From end of anaesthesia till 20-minutes postoperatively

Study Arms (2)

BIS Guided Group

ACTIVE COMPARATOR

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)

ETAG Guided Group

ACTIVE COMPARATOR

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)

Interventions

Bi-spectral Index (BIS QUATRO REF #186-0106) DEVICE

GA will be monitored and controlled with Bi-spectral index (BIS).

BIS Guided Group

End tidal anaesthesia gas concentration (ETAG) DEVICE

GA will be monitored and controlled with end-tidal anaesthesia gas concentration

ETAG Guided 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (5)

Sir Ganga Ram Hospital

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

Location

Prof. L Parthasarathy

Chennai, Tamil Nadu, 600002, India

Location

Post Graduate Institute For Medical Education & Research

Chandigarh, India

Location

Apollo Gleneagles Hospital

Kolkata, 700054, India

Location

P D Hinduja Hospital & Medical Research Centre

Mumbai, India

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amitabh Dutta, MD, PhD

  Sir Ganga Ram Hospital

  STUDY CHAIR

• Jayashree Sood, MD,FFRCA

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant & Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: October 10, 2018
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): March 2, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

IN (5)