Evaluation of Intraoperative Awareness During Laparoscopic Abdominal Surgery and Its Correlation With Processed Electroencephalography Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Association Between Positive Isolated Forearm Technique Responses and Patient State Index Changes
研究概览
简要总结
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.
详细描述
: 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous cerebrovascular disease
- •Psychiatric disorders
- •Cognitive dysfunction
- •ASA physical status >III
- •High frailty
- •Body mass index >30 kg/m²
- •Pregnancy
- •Age <18 years
研究组 & 干预措施
type 0
Unconscious No signal; No response to commands No recall No recall Adequate anesthesia
type1
Intraoperative awareness Signal present Responds to commands No recall No recall or emotional consequences Wakefulness during surgery, erased explicit and implicit memory
type5
Intraoperative awareness Signal present Responds to commands Explicit recall accompanied by distress and/or pain Explicit memory with PTSD/nightmares Awareness with emotional damage
type2
Intraoperative awareness (Cue words provided) Signal present Responds to commands No explicit recall, Implicit memory for provided words No explicit recall; Implicit memory for provided words but no emotional consequences Wakefulness during surgery and subsequent implicit memory
type3
Intraoperative awareness Signal present Responds to commands No recall PTSD/nightmares present but no explicit memory Wakefulness during surgery and implicit emotional memory
type4
Intraoperative awareness Signal present Responds to commands Explicit recall with or without pain Explicit memory present but no emotional consequences Awareness present but resilient patient (no emotional damage)
结局指标
主要结局
Association Between Positive Isolated Forearm Technique Responses and Patient State Index Changes
时间窗: 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.
次要结局
- . Intraoperative Responsiveness(During induction and surgery.)
- . PSI Increase Associated With IFT Positivity(During surgery)
- Postoperative Awareness at 24 Hours(24 hours after surgery.)
- Postoperative Awareness at 2 Weeks(2 weeks after surgery)
- Quality of Recovery(Preoperatively, 24 hours postoperatively, and 2 weeks postoperatively.)
- Postoperative Anxiety(Preoperatively and 2 weeks postoperatively.)
- Dream Recall(2 weeks after surgery)
- Preoperative Anxiety(Preoperatively)
- Cognitive Status(Preoperatively)