Adenotonsillectomy, Dexmedetomidine, Respiratory Tract Infections
Conditions
Brief summary
The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.
Detailed description
Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE). Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.
Interventions
DRUGDexmedetomidine group
That will receive intranasal dexmedetomidine (1.5mcg/kg)
OTHERcontrol group
That will receive the same volume of 2 ml of intranasal normal saline
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children with recent mild URI or asthma. 2. aged from 3 to 10 years 3. ASA Physical Status II, 4. undergoing adenotonsillectomy
Exclusion criteria
1. Parental refusal of participation 2. Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery 3. Lower respiratory tract infection 4. Congenital heart diseases 5. Known hypersensitivity to specific anesthetic agent 6. Liver or renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of peri-operative respiratory adverse effects (PRAE). | From induction to emergence from general anesthesia. | All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedating effects of this drug. | 15 and 30 min after sedation | The sedating effects will be measure using Ramsay sedation scale from 1 to 6 as 1 meaning anxious and agitated, restless, or both. and 6 meaning Unresponsive. |
| Ease of parental separation. | 15 and 30 min after sedation | Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor |
| Face mask acceptance. | 15 and 30 min after sedation | Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor |
| Hemodynamic stability | 15 and 30 min after sedation | hypertension, tachycardia, bradycardia |
Countries
Egypt
Contacts
Primary ContactEman A Azzam, M․B․B․CH
Outcome results
None listed