Clinical trial NCT04820374: The Guiding Significance of Pupil Monitoring in the Perioperative Period
Official title: The Guiding Significance of Pupil Monitoring in the Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pupil Diameter
Pupil Contraction Rate
Pupil Light Reflection
Keywords: Pupil
Cognitive Dysfunction
recovery
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Changes in the level of CAM-ICU scale score
timeFrame: 1,2,3,7 days after surgery
measure: Changes in the level of Mini-Men-tal State Examination scale score
timeFrame: The day before surgery and 1,2,3,7 days after surgery
measure: Changes in the level of Pittsburgh sleep quality index
timeFrame: The day before surgery and 1,2,3,7 days
measure: Changes in the level of pupil light reflection
timeFrame: "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 "
measure: Changes in the level of Polysomnography
timeFrame: "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 "
measure: Changes in the level of pupil diameter
timeFrame: "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:
measure: Changes in the waveform of Narcotrend
timeFrame: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears"
measure: Changes in the level of Heart Rate
timeFrame: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears"
measure: Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)
timeFrame: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears"
measure: Changes in the level of Oxygen saturation
timeFrame: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears"
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
References: