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NCT Number: NCT04820374

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.

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Key information

Conditions

Pupil Diameter Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pupil Contraction Rate Pupil Light Reflection

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 "

  5. 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

  6. 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 "

Secondary outcomes

  1. Changes in the waveform of Narcotrend

    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"

    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

  2. Changes in the level of Heart Rate

    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"

  3. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)

    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"

  4. Changes in the level of Oxygen saturation

    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"

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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