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

NCT01895023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2015-01-06

No results posted yet for this study

Summary

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.

Conditions

  • Inhalational Anesthetics Adverse Reaction
  • Delirium on Emergence
  • Strabismus Following Ocular Surgery

Interventions

DRUG

Dexmedetomidine

The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.

DRUG

Midazolam

The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.

DRUG

Saline

The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Yao Yusheng

    lead OTHER

Principal Investigators

  • Yusheng Yao, M.D. · Fujian Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895023 on ClinicalTrials.gov