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

Phase 2

Completed

• Conditions: Agitation
• Interventions: Drug: saline; Drug: Dexmedetomidine

• Registration Number: NCT02720705
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Study Start: 2016-05
• Primary Completion: 2018-10
• Study Completion: 2018-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Control	saline	2ml oral 0.9%saline half an hour before operation
DEX II	Dexmedetomidine	active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation
DEX I	Dexmedetomidine	active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation

Primary Outcome Measures

Name	Time	Method
The agitation score up to 1hour postoperative.	first postoperative hour	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.

Secondary Outcome Measures

Name	Time	Method
Pain score assessed using the objective pain scale.	up to 1hour postoperative hour	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.

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt