The Guiding Significance of Pupil Monitoring in the Perioperative Period

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.

Study Overview

• Status: Completed
• Conditions: Pupil Diameter; Pupil Contraction Rate; Pupil Light Reflection
• Intervention / Treatment: Procedure: pupil's light and pupil diameter

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • the Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: traditional extubation indications and traditional restoration indoor requirements
Experimental: Extubate the tube according to the pupil index and leave the recovery room	Procedure: pupil'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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the level of CAM-ICU scale score	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.	1,2,3,7 days after surgery
Changes in the level of Mini-Men-tal State Examination scale score	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.	The day before surgery and 1,2,3,7 days after surgery
Changes in the level of Pittsburgh sleep quality index	Assess the patient's sleep quality by asking questions on the scale.The lower the score, the more serious the sleep disorder.	The day before surgery and 1,2,3,7 days
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 "
Changes in the level of Polysomnography	Through the polysomnograph, monitor the patient's sleep during anesthesia, including brain wave changes and sleep stages at different time points	"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 "
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 "

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the waveform of Narcotrend	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	"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 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 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"

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: recovery; Cognitive Dysfunction; Pupil
• Other Study ID Numbers: 20210318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No