Propofol for Treatment on Emergence Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.

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Detailed Description

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Sevoflurane with rapid anesthetic induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. In severe case, it cause injury to the child or to the surgical site and lead to the accidental removal of surgical dressings and intravenous catheters. In case of intense agitation with high risk of self-injury, pharmacologic intervention seems reasonable. Pharmacologic treatment of emergence agitation relies on the administration of IV sedative agents (IV midazolam 0.1 mg/kg12 or propofol 0.5 or 1 mg/kg) or opioid agents (IV fentanyl 1 or 2 mcg/kg). However, these treatments are empirical and were extrapolated from pharmacologic preventive studies performed at the end of surgery or from personal experience. To the investigators knowledge, there is no risk of recurrence of EA after a first episode. Consequently, EA is not per se a factor of increased duration of PACU (post-anaesthesia care unit ) stay, but sedative or opioid agents administered postoperatively to alleviate it might prolong this stay.

Therefore, the investigators design a study to confirm statistically effect of propofol for treatment on emergence agitation after sevoflurane anesthesia in pediatric strabismus surgery through PAED scale. Furthermore duration of PACU stay is checked after propofol administration.

Conditions

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Child Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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PAED > 13

When severe emergence agitation(PAED is 14 or more) is occured, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

When severe emergence agitation(PAED \> 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.

PAED < 14

Caregivers must first try to reassure patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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propofol

When severe emergence agitation(PAED \> 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.

Intervention Type DRUG

Other Intervention Names

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fresofol MCT 1%

Eligibility Criteria

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Inclusion Criteria

* ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.

Exclusion Criteria

* Refusal by parents, neurologic disease, developmental delay, history of any previous surgery, American society of Anesthesiologists physical status score of III or IV, and airway disease

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes