UnknownNot Applicable

Efficacy of BIS Monitoring in Deep Hypnotic State

50 participantsStarted 2023-12-15

Plain-language summary

Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients

Who can participate

Age range

30 Years – 60 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: * Patients aged 30-60 years with an ASA tolerance of 1-2 who will undergo general anesthesia techniques * Operation duration \> 3 hours * The patient agrees to take part in the study. Exclusion Criteria: * Continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents * Massive bleeding that causes hemodynamic disturbances * Severe electrolyte disturbances * Severe liver or kidney function disorders * The patient was decided not to extubate in the operating room

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

Deep Hypnotic State

Timeframe: During surgery and up to 24 hours after surgery

Total use of anesthetic agents

Timeframe: During surgery and up to 24 hours after surgery

Number of Participants with Hypotension and Bradycardia Intraoperative

Timeframe: During surgery and up to 24 hours after surgery

Vasopressor use

Timeframe: Before surgery, during surgery, up to 24 hours after surgery

Incidence of delirium

Timeframe: up to 24 hour after surgery

Incidence of mortality

Timeframe: up to 28 days after surgery

Lenght of stay

Timeframe: From the date of randomization until 28 days after surgery

Trial details

NCT IDNCT06177847

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Hypnotic; Withdrawal State With Delirium trials

Who can participate

Age range

30 Years – 60 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.

What they're measuring

Deep Hypnotic State

Timeframe: During surgery and up to 24 hours after surgery

Total use of anesthetic agents

Timeframe: During surgery and up to 24 hours after surgery

Number of Participants with Hypotension and Bradycardia Intraoperative

Timeframe: During surgery and up to 24 hours after surgery

Vasopressor use

Timeframe: Before surgery, during surgery, up to 24 hours after surgery

Incidence of delirium

Timeframe: up to 24 hour after surgery

Incidence of mortality

Timeframe: up to 28 days after surgery

Lenght of stay

Timeframe: From the date of randomization until 28 days after surgery