This prospective observational study aims to examine the relationship between fluctuations in anesthesia depth, measured by bispectral index (BIS) monitoring during surgery, and changes in patients' postoperative recovery quality.
BIS monitoring is routinely used during general anesthesia to assess the depth of anesthesia, but BIS values often fluctuate over time rather than remaining stable. The clinical significance of this variability is not well understood. In this study, BIS variability during anesthesia induction and maintenance will be evaluated and compared with changes in postoperative recovery quality.
Recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which will be administered before surgery and again on the first postoperative day. The primary outcome of the study will be the change in QoR-15 score from the preoperative baseline to postoperative day one (ΔQoR-15). Delirium screening and routine perioperative clinical data will also be collected.
No additional interventions beyond standard anesthesia care will be performed. The results of this study may help improve understanding of how intraoperative anesthesia stability relates to patient recovery after surgery.
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:
* Adults aged 18 to 65 years
* Scheduled for elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical status I-III
* Planned general anesthesia with routine bispectral index (BIS) monitoring
* Ability to provide written informed consent
Exclusion Criteria:
* History of neurological disease
* Use of neuropsychiatric medications
* Cognitive impairment or mental retardation
* Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire
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.
1This trial is tracking something called BIS variability during general anesthesia for laparoscopic cholecystectomy — can you explain what BIS variability means and whether the way my anesthesia is managed might affect how well I recover after surgery?
2Since this study is measuring quality of recovery using a score called QoR-15, what does that score actually capture, and how would my recovery be assessed before and after the procedure if I were part of this trial?
3This trial is listed as 'Phase NA,' which suggests it's more of an observational or measurement study rather than one testing a new treatment — does that mean there's no experimental intervention involved, and what would actually be different about my care compared to standard surgery?
4Given that this study involves laparoscopic cholecystectomy specifically, is my planned surgery the same type, and would participating in this trial change anything about how my operation or anesthesia would be handled?
5Are there any logistical requirements for participating in this trial, such as extra visits, questionnaires, or monitoring, that I should know about before deciding whether it's worth discussing with my care team?
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
Change in Quality of Recovery-15 (ΔQoR-15) Score
Timeframe: From preoperative baseline to postoperative day one