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Sevoflurane Induced Emergence Agitation

Primary Purpose

Emergence Agitation

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
midazolam
alfentanil
ketamine
Sponsored by
Yeditepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation focused on measuring Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1- 8 years
  • American Society of Anesthesiologist (ASA) I-II,
  • Patients undergoing procedures below the umbilicus

Exclusion Criteria:

  • cardiac diseases
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • psychological or emotional disorders

Sites / Locations

  • Yeditepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

midazolam and alfentanil

midazolam and ketamine

midazolam

Arm Description

Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)

Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)

Midazolam 0.5mg/kg

Outcomes

Primary Outcome Measures

Pediatric Anesthesia Emergence Delirium (PAED) score
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

Secondary Outcome Measures

Parental separation score
Parental separation were evaluated with a 4- point scale in the preoperative period
Mask acceptance
The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

Full Information

First Posted
December 10, 2013
Last Updated
December 26, 2013
Sponsor
Yeditepe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02022488
Brief Title
Sevoflurane Induced Emergence Agitation
Official Title
Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
midazolam and alfentanil
Arm Type
Active Comparator
Arm Description
Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
Arm Title
midazolam and ketamine
Arm Type
Active Comparator
Arm Description
Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
Arm Title
midazolam
Arm Type
Placebo Comparator
Arm Description
Midazolam 0.5mg/kg
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
Group M
Intervention Type
Drug
Intervention Name(s)
alfentanil
Intervention Description
Group MA
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
Group MK
Primary Outcome Measure Information:
Title
Pediatric Anesthesia Emergence Delirium (PAED) score
Description
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Parental separation score
Description
Parental separation were evaluated with a 4- point scale in the preoperative period
Time Frame
7 months
Title
Mask acceptance
Description
The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1- 8 years American Society of Anesthesiologist (ASA) I-II, Patients undergoing procedures below the umbilicus Exclusion Criteria: cardiac diseases pulmonary diseases hepatic diseases renal diseases psychological or emotional disorders
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

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Sevoflurane Induced Emergence Agitation

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