Duzce University
Düzce, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07831590
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Düzce, Turkey (Türkiye)
Location status: Recruiting
: Intraoperative awareness is a clinically important complication of general anesthesia in which patients may experience consciousness and subsequently recall events occurring during anesthesia. Intraoperative responsiveness and postoperative explicit recall represent related but distinct aspects of consciousness during general anesthesia.
This prospective observational cohort study will include adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Approximately 600 participants will be prospectively enrolled.
Before surgery, participants will undergo baseline assessment using the QoR-15, State-Trait Anxiety Inventory, Mini-Mental State Examination, and Beck Anxiety Inventory.
Processed EEG monitoring will be performed using the Masimo SedLine system. The SedLine system will be applied before induction of general anesthesia and maintained throughout the anesthetic period until extubation. PSI values will be recorded at 5-minute intervals from the beginning of surgery until extubation.
The isolated forearm technique will be used to assess intraoperative responsiveness. The first four IFT assessments will be performed at predefined stages during induction and surgery. A fifth IFT assessment will be performed when the clinical course or monitoring suggests possible awakening, including a PSI value above 50 and/or hemodynamic findings such as tachycardia or hypertension. During the IFT, patients will be instructed to respond to a predefined verbal command, and the presence or absence of a response will be recorded.
PSI values corresponding to IFT assessments will be evaluated. Particular attention will be given to increases in PSI associated with positive IFT responses. A positive IFT response together with an increase in PSI will be considered evidence of intraoperative responsiveness and possible intraoperative awareness rather than definitive proof of explicit postoperative awareness.
At the 24th postoperative hour, patients will undergo QoR-15 assessment and structured questioning regarding possible intraoperative awareness and recall. At the second postoperative week, QoR-15 and Beck Anxiety Inventory assessments will be repeated, and dream recall and possible intraoperative awareness will be assessed.
The study will investigate the relationship between processed EEG-derived PSI values, intraoperative responsiveness detected by the isolated forearm technique, and postoperative reports suggestive of awareness. It will also evaluate associations between possible intraoperative awareness and postoperative quality of recovery, anxiety, and dream recall.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the beginning of surgery until extubation
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: During induction and surgery.
Frequency of positive isolated forearm technique responses during general anesthesia.
Time frame: During surgery
Magnitude of PSI increase associated with positive isolated forearm technique responses compared with preceding PSI measurements
Time frame: 24 hours after surgery.
Patient-reported recall or experiences suggestive of intraoperative awareness assessed by structured postoperative questioning.
Time frame: 2 weeks after surgery
Patient-reported recall or experiences suggestive of intraoperative awareness assessed at the second postoperative week.
Time frame: Preoperatively, 24 hours postoperatively, and 2 weeks postoperatively.
Change in QoR-15 score from the preoperative assessment to 24 hours and 2 weeks after surgery.
Time frame: Preoperatively and 2 weeks postoperatively.
Change in Beck Anxiety Inventory score from the preoperative assessment to the second postoperative week and its association with possible intraoperative awareness.
Time frame: 2 weeks after surgery
Presence of dream recall and its association with possible intraoperative awareness.
Time frame: Preoperatively
Preoperative state and trait anxiety levels assessed using the State-Trait Anxiety Inventory
Time frame: Preoperatively
: Preoperative cognitive status assessed using the Mini-Mental State Examination
Contact information is provided by the study sponsor or research team.
Duzce University
Other
Evaluation of Intraoperative Awareness During Laparoscopic Abdominal Surgery and Its Correlation With Processed Electroencephalography Biomarkers
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