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Brain monitor tested to prevent surgery awareness in indians

NCT ID NCT03571945

Knowledge-focused Sponsor: Sir Ganga Ram Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether using a brain activity monitor (BIS) during general anesthesia can lower the chance of patients being aware during surgery. It involves 2,000 Indian adults having elective surgery. Half will have anesthesia guided by BIS, the other half by standard gas monitoring. The goal is to see if BIS works as well in Indian patients as it does in Western populations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bi-spectral Index (BIS) monitoring device
What this could lead to
If successful, this could show that BIS monitoring works as well in Indian patients as in Western populations, potentially improving anesthesia safety.
What could go wrong
This trial is suspended and only observes outcomes without testing a new drug or treatment. Results may not change current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Intraoperative Awareness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraoperative awareness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Apollo Gleneagles Hospital

    Kolkata, 700054, India

  • P D Hinduja Hospital & Medical Research Centre

    Mumbai, India

  • Post Graduate Institute For Medical Education & Research

    Chandigarh, India

  • Prof. L Parthasarathy

    Chennai, Tamil Nadu, 600002, India

  • Sir Ganga Ram Hospital

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

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