Neuro-Mimic Indicators of Anesthesia Depth During General Anesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBaşakşehir Çam & Sakura City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients aged 18-65 years, ASA physical status I-III, undergoing elective abdominal surgery under general anesthesia at Başakşehir Çam and Sakura City Hospital will be included. Eligible patients must have the eye area uncovered and in a position suitable for observation, with surgery expected to last 1-3 hours. Both male and female patients will be enrolled. Head, neck, and eye surgeries or cases requiring full draping of the eye area will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neuro-Mimic Observation Protocol
Other interventionObservation 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in pupil diameter during general anesthesia
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.
Time frame
Intraoperative period (observations at induction, incision, and mid-surgery).Secondary outcomes
1
Presence or absence of eyelid reflex at different anesthesia stages
Eyelid reflex (palpebral reflex) will be assessed as present or absent at three intraoperative stages and analyzed in relation to anesthesia depth.
Time frame
Intraoperative period (induction, incision, mid-surgery).2
Eye position and movements during anesthesia
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.
Time frame
Intraoperative period (induction, incision, mid-surgery).3
Correlation of neuro-mimic indicators with BIS values
Observed eyelid reflex, eye movements, and pupil responses will be correlated with simultaneously recorded BIS values to explore associations with anesthesia depth.
Time frame
Intraoperative period (induction, incision, mid-surgery).4
Early indicators of intraoperative awareness
The relationship between observed neuro-mimic responses (eyelid reflex, eye movements, pupil diameter) and intraoperative awareness risk will be evaluated descriptively.
Time frame
Intraoperative period.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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