The Guiding Significance of Pupil Monitoring in the Perioperative Period

Not Applicable

Completed

• Conditions: Pupil Light Reflection; Pupil Diameter; Pupil Contraction Rate
• Interventions: Procedure: pupil's light and pupil diameter

• Registration Number: NCT04820374
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extubate the tube according to the pupil index and leave the recovery room	pupil's light and pupil diameter	-

Primary Outcome Measures

Name	Time	Method
Changes in the level of Mini-Men-tal State Examination scale score	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	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	"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	"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	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	"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 Outcome Measures

Name	Time	Method
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"	The 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
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"

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China