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Emergence Agitation Between Sevoflurane and Desflurane in Pediatric

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ClinicalTrials.gov Identifier: NCT01235143
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
maliwan oofuvong, Prince of Songkla University

Study Description
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Brief Summary:
Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless, sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of emergence agitation compared to sevoflurane in unpremedicated preschool children under elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported no significant differences between sevoflurane or desflurane anesthesia in children in term of the serious airway complication such as laryngospasm or desaturation excepted the number of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus 18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence agitation between those two. Therefore, the investigators would like to compare the incidence of emergence agitation, recovery profile and respiratory events between desflurane and sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and combined with regional anesthesia.

Condition or disease Intervention/treatment Phase
Children Urologic Diseases Ambulation Difficulty Drug: Desflurane Drug: Sevoflurane Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison the Incidence of Emergence Agitation Between Sevoflurane and Desflurane After Pediatric Urologic Surgery
Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arms and Interventions
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Arm Intervention/treatment
Experimental: desflurane anesthesia
maintenance anesthesia with desflurane
 Drug: Desflurane
Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
Other Name: Suprane (desflurane, USP)
Active Comparator: sevoflurane
maintenance anesthesia with sevoflurane
 Drug: Sevoflurane
Sevoflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
Other Name: sevorane


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of emergence agitation [ Time Frame: average recovery room period was 120 minutes ]
    to compare the incidence of emergence agitation between sevoflurane anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery.


Secondary Outcome Measures :
  1. the recovery profile [ Time Frame: average recovery room period was 120 minutes ]
    to compare the recovery profile such as awakening time. Duration of PACU stay, and also intraopertive and PACU respiratory adverse events between sevoflurane anesthesia and desflurane anesthesia.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children aged 1-9 years, with American Society of Anesthesiologists (ASA) physical status I or II ,
  • scheduled to undergo elective ambulatory urologic surgery under general anesthesia combined with regional block

Exclusion Criteria:

  • emergency procedures
  • medical contraindication to placement of a caudal block
  • mental retardation
  • developmental delay
  • attention-deficit/hyperactivity disorder
  • psychiatric illness
  • a history of paradoxical excitation with sedatives
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01235143


Locations
Thailand
Songklanagarind Hospital
Hat yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Maliwan Oofuvong, MD Prince of Songkla University
More Information
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Responsible Party: maliwan oofuvong, Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01235143     History of Changes
Other Study ID Numbers: PSU 136
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by maliwan oofuvong, Prince of Songkla University:
incidence
emergence agitation
sevoflurane
desflurane
ambulatory pediatric surgery

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Urologic Diseases
Mobility Limitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
 Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Anesthetics
Sevoflurane
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General