Children Clinical Trial
Official title:
Comparison the Incidence of Emergence Agitation Between Sevoflurane and Desflurane After Pediatric Urologic Surgery
Verified date | October 2013 |
Source | Prince of Songkla University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 9 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | Songklanagarind Hospital | Hat yai | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | the recovery profile | 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. | average recovery room period was 120 minutes | Yes |
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