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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02108795
Other study ID # apsj20140331
Secondary ID
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


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
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