The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium

Delirium Clinical Trial

Official title:

The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108795
• Other study ID #: apsj20140331
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: July 14, 2015
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: Yeungnam University College of Medicine
• Contact: Sangjin Park, M.D.
• Phone: 82-53-620-3366
• Email: apsj0718[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Description:

Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I and II

• preschool-aged children undergoing strabismus surgery

Exclusion Criteria:

• psychological disorders

• emotional disorders

• abnormal cognitive development

• developmental delay

• allergy to the drugs in our protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Remifentanil
Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the scale of emergence agitation	A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.	up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.	Yes
Secondary	the effect of remifentanil on the emergence	A blinded observer record duration of anaesthesia, eye-opening time, time to remove laryngeal mask airway, respiratory depression, nausea, and vomiting at the end of surgery, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.	up to 30 minutes after the discharge form postanesthetic care unit	Yes