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

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Ophthalmology

Treatments

Behavioral: To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children.

Study type

Interventional

Funder types

Other

Identifiers

NCT04973150
dpf199438

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

3 to 7 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

350 participants in 2 patient groups

the children were given gauze covering training in one eye or both eyes
Experimental group
Description:
According to the operation method, the children were given gauze covering training in one eye or both eyes.
Treatment:
Behavioral: To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children.
Using regular tablet computer to play cartoon animation video
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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