Intraoperative Awareness and EEG Biomarkers During Laparoscopic Surgery
Official title: Evaluation of Intraoperative Awareness During Laparoscopic Abdominal Surgery and Its Correlation With Processed Electroencephalography Biomarkers
Run by Duzce University · NCT07831590 · Data updated 2026-11-12
This study tests whether processed EEG readings and a simple responsiveness test can reveal awareness during laparoscopic surgery in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Duzce University Academic / other |
| Locations | 1 site (Düzce) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07831590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing elective laparoscopic abdominal surgery with general anesthesia, capable of consent and cognitive interaction, ASA I–III.
✕Probably not a fit
Patients with higher frailty, cognitive impairment, or significant comorbidities beyond ASA III may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort enrolling about 600 adults undergoing elective laparoscopic abdominal surgery under general anesthesia. Researchers will monitor processed EEG with SedLine and record Patient State Index (PSI) every 5 minutes from induction to extubation, while applying the isolated forearm technique to assess intraoperative responsiveness at predefined stages. Baseline patient-reported outcomes and cognitive assessments (QoR-15, STAI, MMSE, BAI) are collected preoperatively. The study aims to explore relationships between EEG biomarkers and intraoperative responsiveness and potential awareness, without any interventional treatment. Findings may inform how EEG monitoring corresponds to conscious experiences during anesthesia.
Why it matters
Potential benefit: If successful, the study could improve understanding of how EEG signals relate to patient awareness, potentially guiding anesthesia management to reduce intraoperative recall.
How similar studies have gone: Prior work using processed EEG and responsiveness techniques has shown associations with intraoperative awareness signals, but this study probes deeper correlations in a larger, single-center cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Elective laparoscopic abdominal surgery planned * General anesthesia planned * Ability to communicate adequately * Adequate cognitive capacity to understand and respond to study procedures * ASA physical status I-III Exclusion Criteria: * Previous cerebrovascular disease * Psychiatric disorders * Cognitive dysfunction * ASA physical status \>III * High frailty * Body mass index \>30 kg/m² * Pregnancy * Age \<18 years
Where it's running
-
Duzce University
Düzce, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: tuğçe altıkardeşler
- Email: tucetin4705@hotmail.com
- Phone: 05535891881
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.