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NCT Number: NCT07199049

Neuro-Mimic Indicators of Anesthesia Depth During General Anesthesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam and Sakura City Hospital

Başakşehir, Istanbul, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Neuro-Mimic Observation Protocol

Other

Observation of eyelid reflex, eye movements, and pupil responses at three standardized intraoperative time points (after induction, during skin incision, and mid-surgery). Parameters will be recorded alongside BIS values without any intervention, device application, or additional risk to patients.

Other names: Eyelid Reflex Monitoring, Eye Movement Observation, Pupil Diameter Assessment

Primary outcomes

  1. Change in pupil diameter during general anesthesia

    Time frame: 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.

Secondary outcomes

  1. Presence or absence of eyelid reflex at different anesthesia stages

    Time frame: Intraoperative period (induction, incision, mid-surgery).

    Eyelid reflex (palpebral reflex) will be assessed as present or absent at three intraoperative stages and analyzed in relation to anesthesia depth.

  2. Eye position and movements during anesthesia

    Time frame: Intraoperative period (induction, incision, mid-surgery).

    Eyeball position (central, upward, downward, eccentric) and spontaneous movements will be observed and documented at three time points. Changes will be evaluated as neuro-mimic indicators of anesthesia depth.

  3. Correlation of neuro-mimic indicators with BIS values

    Time frame: Intraoperative period (induction, incision, mid-surgery).

    Observed eyelid reflex, eye movements, and pupil responses will be correlated with simultaneously recorded BIS values to explore associations with anesthesia depth.

  4. Early indicators of intraoperative awareness

    Time frame: Intraoperative period.

    The relationship between observed neuro-mimic responses (eyelid reflex, eye movements, pupil diameter) and intraoperative awareness risk will be evaluated descriptively.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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