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

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720705
• Other study ID #: AssuitU
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Dexmedetomidine
oral dexmedetomidine
• saline
2ml 0.9% saline administered orally half an hour before induction of anesthesia

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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