The Guiding Significance of Pupil Monitoring in the Perioperative Period

NCT ID: NCT04820374

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

traditional extubation indications and traditional restoration indoor requirements

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

pupil's light and pupil diameter

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20210318

Identifier Type: -

Identifier Source: org_study_id