Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children

Not Applicable

• Conditions: Ophthalmology

• Registration Number: NCT04973150
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. After eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. In clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. How to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-05-01
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-22
• Last Update Posted: 2022-05-24
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Ages 3-7;
2. Selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation);
3. No mental disorders, stunting and low intelligence;
4. There is no other history of surgical hospitalization.

Exclusion Criteria

1. Those who have completed the operation under local anesthesia;
2. People with visual impairment of both eyes;
3. Eyeball removal and/or eye socket implanter;
4. Hearing and language impairment cannot communicate normally;
5. Have a history of taking psychotropic drugs;
6. People with severe organs such as the heart, lungs, brains and kidneys.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety	Up to 24 weeks	The modified Yale preoperative anxiety scale (m-ypas) was used to evaluate the preoperative anxiety. The scale has high reliability and validity (Cronbach's) α The reliability coefficient was 0.936; 91). The scale is often used to evaluate the preoperative anxiety level of children aged 2-12 in the waiting room, going to the operating room, entering the operating room and anesthesia induction period. The questionnaire consists of 5 parts and 22 items, which are language (4 items), vocalization (6 items), emotional expression (4 items), obvious alertness (4 items), and the role of parents (4 items). In addition to the vocal part of 1-6 points, the rest are 1-4 points, the minimum is 0 points, the maximum is 100 points, the higher the score, the higher the anxiety level of the subjects. The scale was evaluated by the anesthesiologist when the child entered the operating room, and the evaluation time was about 2 minutes.

Trial Locations

Locations (1)

peifang Dong; 🇨🇳 Hangzhou, China