NCT02720705

Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

Detailed description

Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors. Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery. The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	oral dexmedetomidine
DRUG	saline	2ml 0.9% saline administered orally half an hour before induction of anesthesia

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-10-01
• Completion: 2018-11-01
• First posted: 2016-03-28
• Last updated: 2020-07-14

Locations

1 site across 1 country: Egypt