Text Size

Emergence Agitation Between Sevoflurane and Desflurane in Pediatric

This study is currently recruiting participants.
Verified July 2011 by Prince of Songkla University
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01235143
First received: November 4, 2010
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Children
Urologic Diseases
Ambulation Difficulty
 Drug: Desflurane
Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison the Incidence of Emergence Agitation Between Sevoflurane and Desflurane After Pediatric Urologic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • the incidence of emergence agitation [ Time Frame: average recovery room period around 2 hr ] [ Designated as safety issue: Yes ]
    to compare the incidence of emergence agitation between sevoflurane anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery.


Secondary Outcome Measures:
  • the recovery profile [ Time Frame: average recovery room period around 2 hr ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 136
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235143

Contacts
Contact: Maliwan Oofuvong, MD 66-816982396 malewan@yahoo.com

Locations
Thailand
Songklanagarind Hospital Recruiting
Hat yai, Songkhla, Thailand, 90110
Contact: Maliwan Oofuvong, MD     66-816982396     malewan@yahoo.com    
Principal Investigator: maliwan oofuvong, MD            
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Maliwan Oofuvong, MD Prince of Songkla University
  More Information

No publications provided

Responsible Party: Assistant Professor Maliwan Oofuvong, MD, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01235143     History of Changes
Other Study ID Numbers: PSU 136
Study First Received: November 4, 2010
Last Updated: July 22, 2011
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Urologic Diseases
Psychomotor Agitation
Mobility Limitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Desflurane
 Isoflurane
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on June 17, 2013