Actively Recruiting
Association Between Intraoperative Bispectral Index Variability and Change in Quality of Recovery-15 Score: A Prospective Observational Study
Led by Sakarya University · Updated on 2026-04-08
126
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how fluctuations in anesthesia depth during surgery, measured by bispectral index (BIS) monitoring, affect patients' recovery quality after surgery. This observational study focuses on adults undergoing elective laparoscopic gallbladder removal under general anesthesia. The goal is to understand the relationship between BIS variability during anesthesia and changes in recovery quality as measured by a specific questionnaire. All participants will receive standard general anesthesia care with BIS monitoring as part of routine practice. BIS values will be recorded throughout the surgery without altering usual anesthesia management. Recovery quality will be assessed before surgery and again on the first day after surgery using the Quality of Recovery-15 (QoR-15) questionnaire. Additional data like delirium screening and perioperative clinical information will also be collected. Participants will complete the QoR-15 questionnaire before surgery and on postoperative day one. Researchers will collect BIS data continuously during the procedure and record other clinical information. The main measure is the change in QoR-15 score from before surgery to the first postoperative day. Additional outcomes include postoperative delirium and pain intensity. The study does not involve interventions beyond routine care and aims to improve understanding of how anesthesia stability impacts recovery.
CONDITIONS
Brief Title
BIS Variability and Change in Quality of Recovery After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of neurological disease
- Use of neuropsychiatric medications
- Cognitive impairment or mental retardation
- Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants who undergo routine anesthesia for elective laparoscopic cholecystectomy are observed. Intraoperative bispectral index (BIS) monitoring data and routine perioperative clinical variables are collected as part of standard care.
1 visit (in-person)
Duration - Preoperative baseline to postoperative day one
Participants complete recovery assessments using the Quality of Recovery-15 questionnaire before surgery and on postoperative day one to evaluate recovery quality and postoperative outcomes.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Serdivan, Turkey (Türkiye), 54000
Actively Recruiting
Research Team
A
Ahmet R Doğan, M.D
A
Ayça Taş Tuna, Prof. Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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