Working… Menu

Sevoflurane Induced Emergence Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02022488
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 30, 2013
Information provided by (Responsible Party):
Sevgi Bilgen, Yeditepe University Hospital

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.

Condition or disease Intervention/treatment Phase
Emergence Agitation Drug: midazolam Drug: alfentanil Drug: ketamine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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

Primary Outcome Measures :
  1. Pediatric Anesthesia Emergence Delirium (PAED) score [ Time Frame: 7 months ]
    Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

Secondary Outcome Measures :
  1. Parental separation score [ Time Frame: 7 months ]
    Parental separation were evaluated with a 4- point scale in the preoperative period

  2. Mask acceptance [ Time Frame: 7 months ]
    The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02022488

Layout table for location information
Yeditepe University Hospital
Istanbul, Turkey, 34752
Sponsors and Collaborators
Yeditepe University Hospital
Layout table for additonal information
Responsible Party: Sevgi Bilgen, Yeditepe University, Yeditepe University Hospital Identifier: NCT02022488    
Other Study ID Numbers: 162
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013
Keywords provided by Sevgi Bilgen, Yeditepe University Hospital:
Emergence delirium
General anesthesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Emergence Delirium
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia