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

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Agitation

Treatments: Drug: Dexmedetomidine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02720705

AssuitU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

DEX I

Active Comparator group

Description:

active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation

Treatment:

Drug: Dexmedetomidine

Saline Control

Placebo Comparator group

Description:

2ml oral 0.9%saline half an hour before operation

Treatment:

Drug: saline

DEX II

Active Comparator group

Description:

active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation

Treatment:

Drug: Dexmedetomidine