BIS variability and change in recovery after laparoscopic gallbladder removal
Association Between Intraoperative Bispectral Index Variability and Change in Quality of Recovery-15 Score: A Prospective Observational Study
This study will try to see if fluctuations in BIS (a monitor of anesthesia depth) during general anesthesia are linked to how well adults recover the day after elective laparoscopic gallbladder removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Sakarya, Serdivan) |
| Trial ID | NCT07454629 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will enroll adults having elective laparoscopic cholecystectomy at a single center without changing routine anesthetic care. Intraoperative BIS data will be recorded during induction and maintenance, filtered for signal quality, and summarized using statistical dispersion measures to quantify variability. Patients will complete the QoR-15 questionnaire before surgery and again on postoperative day one to determine change in recovery (ΔQoR-15). The analysis will test associations between BIS variability and ΔQoR-15 while incorporating delirium screening and routine perioperative clinical data as covariates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 scheduled for elective laparoscopic cholecystectomy with planned general anesthesia and routine BIS monitoring who can provide informed consent and complete the QoR-15.
Not a fit: Patients with preexisting neurological disease, who use neuropsychiatric medications, who have cognitive impairment, or who cannot complete the QoR-15 are excluded and unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, findings could help clinicians recognize whether wide swings in anesthesia depth affect early recovery and inform monitoring or anesthesia practices to improve postoperative comfort and outcomes.
How similar studies have performed: Although BIS-guided anesthesia has been studied for reducing anesthetic dose and awareness risk, the specific link between intraoperative BIS variability and short-term postoperative recovery remains relatively novel and incompletely defined.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sakarya, Serdivan
- Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation — Sakarya, Serdivan, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ayça Taş Tuna, Professor, M.D. — Sakarya University Faculty of Medicine
- Study coordinator: Ahmet R Doğan, M.D
- Email: a.ridvandogan@gmail.com
- Phone: +905427988070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.