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Clinical Trials/NCT03807011
NCT03807011
Completed
Not Applicable

The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

Yeungnam University College of Medicine2 sites in 1 country90 target enrollmentJuly 7, 2017

Overview

Phase
Not Applicable
Intervention
fentanyl group
Conditions
Emergence Agitation
Sponsor
Yeungnam University College of Medicine
Enrollment
90
Locations
2
Primary Endpoint
incidence of postoperative agitation
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Registry
clinicaltrials.gov
Start Date
July 7, 2017
End Date
October 5, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eun Kyung Choi

Professor

Yeungnam University College of Medicine

Eligibility Criteria

Inclusion Criteria

  • patients undergoing elective subumbilical surgery,
  • physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria

  • history of airway problem,
  • upper respiratory tract infection within 2 weeks,
  • developmental delay,
  • neurological or psychological disease,
  • history of allergy to the drugs in our protocol were excluded in this study.

Arms & Interventions

fentanyl

A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction

Intervention: fentanyl group

remifentanil

Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery

Intervention: remifentanil group

Outcomes

Primary Outcomes

incidence of postoperative agitation

Time Frame: 30 minutes in the recovery room

0=none; 1=occur

severity of postoperative agitation

Time Frame: 30 minutes in the recovery room

Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

Study Sites (2)

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