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Sevoflurane Induced Emergence Agitation

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ClinicalTrials.gov Identifier: NCT02022488
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Sevgi Bilgen, Yeditepe University Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date December 30, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
Pediatric Anesthesia Emergence Delirium (PAED) score [ Time Frame: 7 months ]
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Parental separation score [ Time Frame: 7 months ]
    Parental separation were evaluated with a 4- point scale in the preoperative period
  • Mask acceptance [ Time Frame: 7 months ]
    The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevoflurane Induced Emergence Agitation
Official Title  ICMJE Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Emergence Agitation
Intervention  ICMJE
  • Drug: midazolam
    Group M
  • Drug: alfentanil
    Group MA
  • Drug: ketamine
    Group MK
Study Arms  ICMJE
  • Active Comparator: midazolam and alfentanil
    Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
    Interventions:
    • Drug: midazolam
    • Drug: alfentanil
  • Active Comparator: midazolam and ketamine
    Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
    Interventions:
    • Drug: midazolam
    • Drug: ketamine
  • Placebo Comparator: midazolam
    Midazolam 0.5mg/kg
    Intervention: Drug: midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2013)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02022488
Other Study ID Numbers  ICMJE 162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sevgi Bilgen, Yeditepe University Hospital
Study Sponsor  ICMJE Yeditepe University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yeditepe University Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP