Agitation
Conditions
Keywords
sevoflurane emergence agitation
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.
Interventions
DRUGDexmedetomidine
oral dexmedetomidine
DRUGsaline
2ml 0.9% saline administered orally half an hour before induction of anesthesia
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed