Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From Gene… (NCT06302517) | Clinical Trial Compass
CompletedNot Applicable
Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia
China134 participantsStarted 2020-09-01
Plain-language summary
①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia
②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU)
Who can participate
Age range
20 Years – 80 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
. age ranging from 20 to 80 years
. estimated operation time of 2 to 3 h
. body mass index ≤30 kg/m2
. normal preoperative heart, liver, lung, and renal function.
Exclusion criteria
. Past cognitive impairment (dementia, cognitive impairment, mental illness or mental disorder)
. Complex injuries: multiple fractures, chest and abdomen, pelvic and sacral trauma, head trauma, etc
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
Ricker sedation-agitation scale
Timeframe: ￭evaluate immediately after recovery and tracheal intubation removal ￭every five minutes after that ￭take the highest value until the patient leave PACU
2
The nursing activity score (NAS)
Timeframe: ￭at the begin of the patient enter PACU ￭end with the transfer out of the PACU ￭any nursing activitise will be scored
Timeframe: ￭ at the beginning of surgery (T0), ￭at the time of extubation (T1), ￭10 minutes after extubation (T2), ￭at the time of leaving the PACU (T3: when patients were transferred from the PACU to the ward).
4
Comparison of complications during the PACU period
Timeframe: The patients were transferred to PACU after surgery, the period during the PACU
5
The comprehensive satisfaction score
Timeframe: The patients were followed up 24 hours after surgery
Trial details
NCT IDNCT06302517
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine