The Guiding Significance of Pupil Monitoring in the Perioperative Period

NCT04820374 | Completed

• 1 other identifier: 20210318
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pupil Diameter; Pupil Contraction Rate; Pupil Light Reflection

Keywords

Pupil; Cognitive Dysfunction; recovery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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 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"

Study Arms (2)

traditional extubation indications and traditional restoration indoor requirements

NO INTERVENTION

Extubate the tube according to the pupil index and leave the recovery room

EXPERIMENTAL

Procedure: pupil's light and pupil diameter

Interventions

pupil's light and pupil diameter PROCEDURE

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

Extubate the tube according to the pupil index and leave the recovery room

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 29, 2021
• Study Start: November 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

CN (1)