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

Primary Purpose

Delirium

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remifentanil

Placebo

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, Yeungnam University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

remifentanil group

control

Arm Description

Remifentanil 0.05 ug/kg/min is infused to the patients.

Normal saline 0.2 ml/kg/hour is infused to the patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02108795

First Posted

March 31, 2014

Last Updated

July 14, 2015

Sponsor

Yeungnam University College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02108795

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

April 2016 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

remifentanil group

Arm Type

Experimental

Arm Description

Remifentanil 0.05 ug/kg/min is infused to the patients.

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

Normal saline 0.2 ml/kg/hour is infused to the patients

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Other Intervention Name(s)

remifentanil (ultiva)

Intervention Description

Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

the scale of emergence agitation

Description

Time Frame

up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.

Secondary Outcome Measure Information:

Title

the effect of remifentanil on the emergence

Description

Time Frame

up to 30 minutes after the discharge form postanesthetic care unit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sangjin Park, M.D.

Phone

82-53-620-3366

apsj0718@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sangjin Park, M.D.

Organizational Affiliation

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

City

Daegu

ZIP/Postal Code

705-035

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Duckhee Lee, M.D.

Phone

82-53-620-3365

apsj0718@naver.com

First Name & Middle Initial & Last Name & Degree

Sangjin Park, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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