Clinical trial NCT02720705: Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children
Official title: Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Agitation
Keywords: sevoflurane emergence agitation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II patients
* aged 2-6 years
* patient scheduled for elective tonsillectomy due to recurrent
* chronic tonsillitis

Exclusion Criteria:

* patients with known hypersensitivity to medication drugs
* coagulation disorders
* thrombocytopenia
* significant cardiac
* renal
* pulmonary
* hepatic disease

Primary outcomes:
measure: The agitation score up to 1hour postoperative.
timeFrame: first postoperative hour
Secondary outcomes:
measure: Pain score assessed using the objective pain scale.
timeFrame: up to 1hour postoperative hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt
name: Halla s Abdel-Ghaffar Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. [Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.