BIS Variability and Change in Quality of Recovery After Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSakarya University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

126 Participants
are grouped into 1 trial group
Group A: Elective Laporoscopic Cholecystectomy Patients Undergoing General Anesthesia

Trial outcomes

Primary outcomes

1

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).

Time frame
From preoperative baseline to postoperative day one

Secondary outcomes

1

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 (%).

Time frame
From preoperative baseline to early postoperative recovery in the post-anesthesia care unit (PACU), within the first 2 hours after anesthesia
2

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.

Time frame
Postoperative day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.