Skip to content

BIS Variability and Change in Quality of Recovery After Surgery

Association Between Intraoperative Bispectral Index Variability and Change in Quality of Recovery-15 Score: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07454629
Enrollment
126
Registered
2026-03-06
Start date
2026-01-01
Completion date
2026-06-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bispectral Index Variability During General Anesthesia and Postoperative Recovery, Cholecystectomy, Laparoscopic

Keywords

Bispectral Index, Anesthesia Depth, Quality of Recovery, General Anesthesia, Postoperative Recovery, Bispectral Index Variability

Brief summary

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.

Detailed description

Bispectral index (BIS) monitoring is widely used in routine anesthesia practice to assess anesthetic depth using processed electroencephalographic signals. Although absolute BIS values are commonly targeted during anesthesia, BIS readings frequently exhibit intraoperative fluctuations rather than remaining stable. The clinical relevance of this variability, particularly in relation to postoperative recovery outcomes, remains insufficiently characterized. This prospective observational study is designed to evaluate the association between intraoperative BIS variability and changes in postoperative recovery quality. Adult patients undergoing elective laparoscopic cholecystectomy under standardized general anesthesia will be included. No experimental intervention or protocol-driven modification of anesthetic management will be applied beyond routine clinical care. BIS data will be obtained as part of standard anesthesia monitoring and exported from the BIS monitor at the end of each procedure. Only BIS measurements meeting predefined signal quality criteria will be included in the analysis. BIS variability will be quantified using statistical dispersion measures derived from filtered BIS data during predefined anesthesia phases, including induction and maintenance. Postoperative recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 will be administered preoperatively to establish baseline status and repeated on postoperative day one. The primary outcome will be defined as the change in QoR-15 score from baseline to postoperative day one (ΔQoR-15). Screening for postoperative delirium and routine perioperative clinical variables will be collected as secondary or exploratory outcomes. Statistical analyses will focus on assessing the association between BIS variability metrics and ΔQoR-15, with additional analyses performed to account for relevant perioperative variables. The findings of this study are expected to contribute to a better understanding of how intraoperative anesthetic stability relates to patient-centered recovery outcomes following surgery.

Interventions

None listed

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Quality of Recovery-15 (ΔQoR-15) ScoreFrom preoperative baseline to postoperative day oneThe 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

MeasureTime frameDescription
Incidence of Postoperative Delirium (Nu-DESC ≥ 2)From preoperative baseline to early postoperative recovery in the post-anesthesia care unit (PACU), within the first 2 hours after anesthesiaPostoperative 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 day 1Postoperative 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAyça Taş Tuna, Professor, M.D.

Sakarya University Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026