Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Y

Yao Yusheng

Status and phase

Completed
Phase 4

Conditions

Strabismus Following Ocular Surgery
Delirium on Emergence
Inhalational Anesthetics Adverse Reaction

Treatments

Drug: Saline
Drug: Dexmedetomidine
Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01895023
FujianPH-TRC-130615

Details and patient eligibility

About

Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families. Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.

Full description

Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.

Enrollment

156 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

Exclusion criteria

mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

156 participants in 3 patient groups, including a placebo group

Dexmedetomidine group
Experimental group
Description:
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Treatment:
Drug: Dexmedetomidine
Midazolam group
Active Comparator group
Description:
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Treatment:
Drug: Midazolam
Placebo Group
Placebo Comparator group
Description:
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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