Sevoflurane Induced Emergence Agitation

December 26, 2013 updated by: Sevgi Bilgen, Yeditepe University Hospital

Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Yeditepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: midazolam and alfentanil
Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
Drug: midazolam
Group M
Drug: alfentanil
Group MA
Active Comparator: midazolam and ketamine
Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
Drug: midazolam
Group M
Drug: ketamine
Group MK
Placebo Comparator: midazolam
Midazolam 0.5mg/kg
Drug: midazolam
Group M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anesthesia Emergence Delirium (PAED) score
Time Frame: 7 months
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental separation score
Time Frame: 7 months
Parental separation were evaluated with a 4- point scale in the preoperative period
7 months
Mask acceptance
Time Frame: 7 months
The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 26, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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