Emergence Agitation Between Sevoflurane and Desflurane in Pediatric

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	November 5, 2010
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