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Clinical Trials/NCT04820374
NCT04820374
Completed
Not Applicable

The Guiding Significance of Pupil Monitoring in the Perioperative Period

Yangzhou University1 site in 1 country80 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pupil Diameter
Sponsor
Yangzhou University
Enrollment
80
Locations
1
Primary Endpoint
Changes in the level of Mini-Men-tal State Examination scale score
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
June 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Zhang

Director

Yangzhou University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Changes in the level of Mini-Men-tal State Examination scale score

Time Frame: The day before surgery and 1,2,3,7 days after surgery

Assess 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 CAM-ICU scale score

Time Frame: 1,2,3,7 days after surgery

First, 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.

Changes in the level of Polysomnography

Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 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 pupil diameter

Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,3minafter intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 day after surgery "

Changes in the level of Pittsburgh sleep quality index

Time Frame: The day before surgery and 1,2,3,7 days

Assess 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 reflection

Time Frame: "before surgery", "the time of intubation", the time of extubation", "1min,3minafter intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 day after surgery "

Secondary Outcomes

  • Changes in the level of Heart Rate("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 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 waveform of Narcotrend("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 saturation("before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears")

Study Sites (1)

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