Emergence Agitation in Pediatric Strabismus Surgery

Sponsor

Yeungnam University College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03807011

Collaborator

(none)

Enrollment

Locations

Arms

14.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation	Drug: fentanyl group Drug: remifentanil group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 7, 2017

Actual Primary Completion Date :

Oct 5, 2018

Actual Study Completion Date :

Oct 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: fentanyl A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction	Drug: fentanyl group fentanyl 2 μg/kg
Active Comparator: remifentanil Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery	Drug: remifentanil group remifentanil 0.2 μg/kg/min

Arm

Intervention/Treatment

Active Comparator: fentanyl

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

Drug: fentanyl group

fentanyl 2 μg/kg

Active Comparator: remifentanil

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

Drug: remifentanil group

remifentanil 0.2 μg/kg/min

Outcome Measures

Primary Outcome Measures

incidence of postoperative agitation [5 minutes in the recovery room]
0=none; 1=occur
incidence of postoperative agitation [30 minutes in the recovery room]
0=none; 1=occur
severity of postoperative agitation [5 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)
severity of postoperative agitation [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)