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The Guiding Significance of Pupil Monitoring in the Perioperative Period

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ClinicalTrials.gov Identifier: NCT04820374
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Zhuan Zhang, Yangzhou University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pupil Diameter Pupil Contraction Rate Pupil Light Reflection Procedure: pupil's light and pupil diameter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Guiding Significance of Pupil Monitoring in the Perioperative Period
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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" ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820374


Contacts
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Contact: Zhang Zhuan, professor +8615062791355 zhangzhuancg@163.com

Locations
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China, Jiangsu
the Affiliated Hospital of Yangzhou University Recruiting
Yangzhou, Jiangsu, China
Contact: Zhang Zhuan, Professor    +8615062791355    zhangzhuancg@163.com   
Sponsors and Collaborators
Yangzhou University
More Information
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Responsible Party: Zhuan Zhang, Director, Yangzhou University
ClinicalTrials.gov Identifier: NCT04820374    
Other Study ID Numbers: 20210318
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Zhang, Yangzhou University:
Pupil
Cognitive Dysfunction
recovery