Evaluation of Intraoperative Awareness and Its Correlation With Processed EEG Biomarkers During Laparoscopic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuzce University
About this trial
This prospective observational cohort study aims to evaluate intraoperative responsiveness and possible intraoperative awareness in adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia and to investigate their relationship with processed electroencephalography (EEG) biomarkers.
Approximately 600 patients will be enrolled. Preoperative assessment will include the 15-item Quality of Recovery questionnaire (QoR-15), State-Trait Anxiety Inventory (STAI), Mini-Mental State Examination (MMSE), and Beck Anxiety Inventory (BAI).
Processed EEG monitoring will be performed using the Masimo SedLine system. The system will be applied before induction of general anesthesia and maintained throughout the anesthetic period until extubation. Patient State Index (PSI) values will be recorded at 5-minute intervals from the beginning of surgery until extubation.
The isolated forearm technique (IFT) will be performed five times during predefined stages of anesthesia and surgery. The fifth assessment will be performed at any stage of surgery when there is clinical or processed EEG evidence suggesting possible awakening, including a PSI value above 50 and/or accompanying hemodynamic changes such as tachycardia or hypertension.
Postoperative assessment will be performed at the 24th postoperative hour and at the second postoperative week. At 24 hours, QoR-15 and structured awareness questioning will be performed. At two weeks, QoR-15, Beck Anxiety Inventory, dream recall, and further assessment of possible intraoperative awareness will be performed.
The study will investigate the relationship between PSI changes, isolated forearm technique responses, and postoperative reports suggestive of intraoperative awareness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Elective laparoscopic abdominal surgery planned
General anesthesia planned
Ability to communicate adequately
Disqualifiers
Previous cerebrovascular disease
Psychiatric disorders
Cognitive dysfunction
ASA physical status >III
Trial population
The study population will consist of adult patients aged 18 years or older who are scheduled for elective laparoscopic abdominal surgery under general anesthesia. Patients who meet the predefined inclusion criteria and do not meet any exclusion criteria will be prospectively enrolled. The planned sample size is approximately 600 participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: type 0
Group B: type1
Group C: type2
Group D: type3
Group E: type4
Group F: type5
Trial outcomes
Primary outcomes
1
Association Between Positive Isolated Forearm Technique Responses and Patient State Index Changes
The primary outcome is the association between positive responses obtained using the isolated forearm technique and changes in Patient State Index (PSI) values during general anesthesia. PSI values will be recorded at 5-minute intervals from the beginning of surgery until extubation. PSI changes occurring during or immediately surrounding positive IFT responses will be evaluated.
Time frame
From the beginning of surgery until extubationSecondary outcomes
1
. Intraoperative Responsiveness
Frequency of positive isolated forearm technique responses during general anesthesia.
Time frame
During induction and surgery.2
. PSI Increase Associated With IFT Positivity
Magnitude of PSI increase associated with positive isolated forearm technique responses compared with preceding PSI measurements
Time frame
During surgery3
Postoperative Awareness at 24 Hours
Patient-reported recall or experiences suggestive of intraoperative awareness assessed by structured postoperative questioning.
Time frame
24 hours after surgery.4
Postoperative Awareness at 2 Weeks
Patient-reported recall or experiences suggestive of intraoperative awareness assessed at the second postoperative week.
Time frame
2 weeks after surgerySponsors and contacts
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Source ClinicalTrials.gov