Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
RECRUITING
Sakarya
Contact Information
Primary
Ahmet R Doğan, M.D
a.ridvandogan@gmail.com
+905427988070
Backup
Ayça Taş Tuna, Prof. Dr
aycatas@yahoo.com
+90 532 300 48 26
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 126
Treatments
Elective Laporoscopic Cholecystectomy Patients Undergoing General Anesthesia
This cohort consists of adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. All participants will receive routine anesthetic management according to standard clinical practice. No experimental intervention or protocol-driven modification of anesthesia care will be applied.~Intraoperative bispectral index (BIS) monitoring will be used as part of standard anesthesia monitoring. BIS data and routine perioperative clinical variables will be recorded for observational analysis. Postoperative recovery will be assessed using validated questionnaires administered before surgery and on postoperative day one. The study involves a single observational cohort without a comparison or control group.
Related Therapeutic Areas
Sponsors
Leads: Sakarya University

This content was sourced from clinicaltrials.gov