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临床试验/NCT07199049
NCT07199049已完成不适用

Monitoring Eyelid Reflex, Eye Movements, and Pupil Responses in Patients Undergoing General Anesthesia: Neuro-Mimic Indicators of Anesthesia Depth

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
Change in pupil diameter during general anesthesia

研究概览

简要总结

This prospective observational study will evaluate neuro-mimic indicators of anesthesia depth, including eyelid reflex, eyeball movements, and pupil responses, in patients undergoing elective surgery under general anesthesia. Sixty adult patients will be observed at three standardized time points: after induction, during skin incision, and mid-surgery. All parameters will be recorded alongside bispectral index (BIS) monitoring. The study aims to determine whether these observable signs correlate with anesthesia depth, contribute to early detection of intraoperative awareness, and provide a basis for developing non-invasive depth monitoring systems.

详细描述

Accurate assessment of anesthesia depth is essential to ensure patient safety and reduce the risk of intraoperative awareness. Current technological monitoring tools such as BIS do not always provide sufficient reliability. Neuro-mimic indicators, including eyelid reflex, spontaneous and stimulus-related eye movements, and pupil responses, may offer additional insights into anesthesia depth. This observational, prospective, non-interventional study will enroll 60 adult patients (aged 18-65, ASA I-III) scheduled for elective abdominal surgeries lasting 1-3 hours under general anesthesia at Başakşehir Çam and Sakura City Hospital. Observations will be performed at three intraoperative stages: post-induction, skin incision, and mid-surgery. Parameters include palpebral reflex, eyeball position and movement, and pupil diameter, all systematically documented alongside BIS values. The primary endpoint is the change in pupil diameter across three time points. Secondary outcomes include the presence or absence of eyelid reflex, eye movements, and their correlations with BIS values. Data will be analyzed using repeated measures ANOVA, McNemar test, correlation analyses, and appropriate non-parametric tests where necessary. The study is entirely observational and involves no additional interventions or risks for patients. Results may provide evidence for the integration of observable physiological signs into anesthesia monitoring practice and contribute to the development of contactless depth monitoring systems.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include patients aged 18-65 who will undergo elective abdominal surgery (e.g., cholecystectomy/gastrectomy/colorectal surgery/prostatectomy/hysterectomy, etc.) under general anesthesia, with a planned duration of 1-3 hours.
  • Patients whose eye area is left uncovered and who are in a position suitable for observation
  • Patients who have signed the informed consent form
  • Patients with an ASA score of I-III

排除标准

  • Patients undergoing surgical procedures in the head, neck, or face region (e.g., ENT, eye, jaw surgery, neurosurgery, thyroid/parathyroid)
  • Patients whose eye area must be completely covered with a sterile drape
  • Patients with an ASA score of IV or higher
  • Individuals with neurological disorders and impaired pupil response, patients who have previously undergone eye trauma or surgery and cannot undergo pupil evaluation
  • Patients who are unable to communicate and cannot provide informed consent
  • Emergency surgeries (e.g., appendectomy/ileus/gastrointestinal perforation/cesarean section/gunshot wounds/stab wounds/multiple trauma/traffic accidents, etc.)
  • Individuals who have previously been included in this study (to prevent repeated inclusion)

结局指标

主要结局

Change in pupil diameter during general anesthesia

时间窗: Intraoperative period (observations at induction, incision, and mid-surgery).

Pupil diameter (mm) will be measured and compared at three intraoperative stages: after induction and intubation, during skin incision, and mid-surgery. The change over time will be analyzed as an indicator of anesthesia depth.

次要结局

  • Presence or absence of eyelid reflex at different anesthesia stages(Intraoperative period (induction, incision, mid-surgery).)
  • Eye position and movements during anesthesia(Intraoperative period (induction, incision, mid-surgery).)
  • Early indicators of intraoperative awareness(Intraoperative period.)
  • Correlation of neuro-mimic indicators with BIS values(Intraoperative period (induction, incision, mid-surgery).)

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emine OZCAN

Principal Investigator

Başakşehir Çam & Sakura City Hospital

研究点 (1)

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