Emergence Agitation Between Sevoflurane and Desflurane in Pediatric - Full Text View

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:

Drug Information available for: Sevoflurane Desflurane

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 was 120 minutes ] [ 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 was 120 minutes ] [ 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.


Enrollment:	136
Study Start Date:	May 2010
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (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 Other Name: sevorane

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Eligibility


Ages Eligible for Study:	1 Year to 9 Years (Child)
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	maliwan oofuvong, Assistant Professor, 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:	October 8, 2013
Health Authority:	Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:


incidence emergence agitation sevoflurane desflurane ambulatory pediatric surgery

Additional relevant MeSH terms:


Psychomotor Agitation Urologic Diseases Mobility Limitation Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms	Anesthetics Sevoflurane Desflurane Isoflurane Central Nervous System Depressants Physiological Effects of Drugs Platelet Aggregation Inhibitors Anesthetics, Inhalation Anesthetics, General

ClinicalTrials.gov processed this record on September 23, 2016