About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of neurological disease
Use of neuropsychiatric medications
Cognitive impairment or mental retardation
Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire
Trial population
The study population consists of adult patients aged 18 to 65 years undergoing elective laparoscopic cholecystectomy under general anesthesia. All participants will receive routine perioperative care according to standard clinical practice, including intraoperative bispectral index (BIS) monitoring. The study includes a single prospective observational cohort, and no experimental intervention or alteration of standard anesthesia management will be performed. Participants will be assessed preoperatively and postoperatively to evaluate changes in recovery quality following surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Quality of Recovery-15 (ΔQoR-15) Score
The primary outcome is the change in postoperative recovery quality measured using the Quality of Recovery-15 (QoR-15) questionnaire. ΔQoR-15 is defined as the difference between the postoperative day one QoR-15 total score and the preoperative baseline QoR-15 total score. The QoR-15 is a validated 15-item questionnaire with total scores ranging from 0 to 150 points, where higher scores indicate better recovery quality. ΔQoR-15 will be analyzed as a continuous variable (points).
Secondary outcomes
Incidence of Postoperative Delirium (Nu-DESC ≥ 2)
Postoperative delirium will be assessed using the Nursing Delirium Screening Scale (Nu-DESC). Delirium will be defined as a Nu-DESC total score ≥ 2 during early postoperative recovery in the PACU. The outcome will be reported as the percentage of patients meeting delirium criteria (%).
Postoperative Pain Intensity (VAS)
Postoperative pain intensity will be assessed using a visual analog scale (VAS) as part of routine clinical evaluation during the early postoperative period. The relationship between intraoperative BIS variability and postoperative pain scores will be explored as a secondary outcome.
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