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The Guiding Significance of Pupil Monitoring in the Perioperative Period

The Guiding Significance of Pupil Monitoring in the Perioperative Period

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04820374
Enrollment
80
Registered
2021-03-29
Start date
2020-11-01
Completion date
2021-06-30
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupil Contraction Rate, Pupil Diameter, Pupil Light Reflection

Keywords

Pupil, Cognitive Dysfunction, recovery

Brief summary

The pupil diameter is affected by both sympathetic and parasympathetic nerves, and its latency and response amplitude mainly reflect the functional status of the parasympathetic nerve. Clinically, the diagnosis of neurological diseases can often be made based on changes in pupils. An appropriate depth of anesthesia can cause minimal damage to the body after surgery, thereby reducing the impact on brain function and cognitive function. The occurrence of postoperative delirium will have adverse effects on the prognosis of patients, such as prolonging the hospital stay, increasing the mortality of patients after surgery, and increasing early postoperative cognitive dysfunction.

Interventions

PROCEDUREpupil's light and pupil diameter

It is necessary to meet the requirement that the pupil's light reflection is slightly restored to the state of entering the room, and then the tube is extubated and the pupil diameter and the light reflection are restored to the state of entering the room, leaving the recovery room

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Elderly patients undergoing general anesthesia for tracheal intubation, aged ≥65 years, operation time ≥2 hours, ASA classification I-III, and postoperative hospital stay for at least one week.

Exclusion criteria

1. It is known that this study involves persons who are allergic to general anesthetics; 2. Patients with previous eye diseases; 3. Head and neck surgery is not conducive to measurement; 4. Patients with preoperative MMSE score less than 24 points or dementia due to various diseases; 5. Patients planning to undergo neurosurgery; 6. Those who use sedatives or antipsychotics before surgery; 7. Patients with known central nervous system diseases, such as mental illness; Patients with hearing or vision impairment and unable to communicate normally.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the level of pupil diameterbefore surgery, the time of intubation, the time of extubation, 1min,3minafter intubation, 10min,20min, 30min after extubation, the reflection of light appears1,2,3,7 day after surgery
Changes in the level of Mini-Men-tal State Examination scale scoreThe day before surgery and 1,2,3,7 days after surgeryAssess the cognitive function of the patient by asking questions on the patient scale.A score of 27 to 30 indicates normal cognitive function, and a score below 27 indicates cognitive dysfunction.
Changes in the level of Pittsburgh sleep quality indexThe day before surgery and 1,2,3,7 daysAssess the patient's sleep quality by asking questions on the scale.The lower the score, the more serious the sleep disorder.
Changes in the level of pupil light reflectionbefore surgery, the time of intubation, the time of extubation, 1min,3minafter intubation, 10min,20min, 30min after extubation, the reflection of light appears1,2,3,7 day after surgery
Changes in the level of Polysomnographybefore surgery, the time of intubation, the time of extubation, 1min,3min after intubation, 10min,20min, 30min after extubation, the reflection of light appears1,2,3,7 day after surgery Through the polysomnograph, monitor the patient's sleep during anesthesia, including brain wave changes and sleep stages at different time points
Changes in the level of CAM-ICU scale score1,2,3,7 days after surgeryFirst, evaluate the patient's state of consciousness based on the patient's behavior, and decide whether to proceed with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.The lower the score, the more likely the patient is to suffer from delirium. questions to score, and evaluate whether the patient has delirium based on the score. with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.

Secondary

MeasureTime frameDescription
Changes in the level of Heart Ratebefore surgery, the time of intubation, the time of extubation, 1min,3min after intubation, 10min,20min, 30min after extubation, the reflection of light appears
Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)before surgery, the time of intubation, the time of extubation, 1min,3min after intubation, 10min,20min, 30min after extubation, the reflection of light appears
Changes in the level of Oxygen saturationbefore surgery, the time of intubation, the time of extubation, 1min,3min after intubation, 10min,20min, 30min after extubation, the reflection of light appears
Changes in the waveform of Narcotrendbefore surgery, the time of intubation, the time of extubation, 1min,3min after intubation, 10min,20min, 30min after extubation, the reflection of light appearsThe outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026