NCT01235143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

November 4, 2010

Last Update Submit

October 8, 2013

Conditions

ChildrenUrologic DiseasesAmbulation Difficulty

Keywords

incidenceemergence agitationsevofluranedesfluraneambulatory pediatric surgery

Outcome Measures

Primary Outcomes (1)

  • the incidence of emergence agitation

    to compare the incidence of emergence agitation between sevoflurane anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery.

    average recovery room period was 120 minutes

Secondary Outcomes (1)

  • the recovery profile

    average recovery room period was 120 minutes

Study Arms (2)

desflurane anesthesia

EXPERIMENTAL

maintenance anesthesia with desflurane

Drug: Desflurane

sevoflurane

ACTIVE COMPARATOR

maintenance anesthesia with sevoflurane

Drug: Sevoflurane

Interventions

DesfluraneDRUG

Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery

Also known as: Suprane (desflurane, USP)
desflurane anesthesia
SevofluraneDRUG

Sevoflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery

Also known as: sevorane
sevoflurane

Eligibility Criteria

Age1 Year - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Urologic DiseasesMobility LimitationEmergence Delirium

Interventions

DesfluraneSevoflurane

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Maliwan Oofuvong, MD

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

TH(1)