Incidence of Intraoperative Awareness in Indian Patient Population (NCT03571945) | Clinical Trial Compass
SuspendedNot Applicable
Incidence of Intraoperative Awareness in Indian Patient Population
Stopped: Due to Coronavirus infection decrease in elective case list , also lack of response from other centers
India2,000 participantsStarted 2018-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of intraoperative awareness
Timeframe: From end of anaesthesia till 30-days postoperatively