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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEX I<br>active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation | Drug: Dexmedetomidine<br>* oral dexmedetomidine<br>* Other names: precedex;|
| Placebo Comparator: Saline Control<br>2ml oral 0.9%saline half an hour before operation | Drug: saline<br>* 2ml 0.9% saline administered orally half an hour before induction of anesthesia<br>* Other names: 0.9% saline;|
| Active Comparator: DEX II<br>active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation | Drug: Dexmedetomidine<br>* oral dexmedetomidine<br>* Other names: precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The agitation score up to 1hour postoperative. | Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min. | first postoperative hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessed using the objective pain scale. | Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min. | up to 1hour postoperative hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane emergence agitation