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| Sponsor: | Prince of Songkla University |
|---|---|
| Information provided by: | Prince of Songkla University |
| ClinicalTrials.gov Identifier: | NCT01235143 |
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 |
| 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 |
|---|---|
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Experimental: desflurane anesthesia
maintenance anesthesia with desflurane
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Drug: Desflurane
Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
Other Name: Suprane (desflurane, USP)
|
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maliwan Oofuvong, MD | 66-816982396 | malewan@yahoo.com |
| Thailand | |
| Songklanagarind Hospital | Recruiting |
| Hat yai, Songkhla, Thailand, 90110 | |
| Contact: Maliwan Oofuvong, MD 66-816982396 malewan@yahoo.com | |
| Principal Investigator: maliwan oofuvong, MD | |
| Principal Investigator: | Maliwan Oofuvong, MD | Prince of Songkla University |
More Information
| 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 |
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incidence emergence agitation sevoflurane desflurane ambulatory pediatric surgery |
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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 |