RecruitingNCT07454629

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


Sponsor

Sakarya University

Enrollment

126 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • History of neurological disease
  • Use of neuropsychiatric medications
  • Cognitive impairment or mental retardation
  • Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire

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Locations(1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Serdivan, Turkey (Türkiye)

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NCT07454629


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