Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection

Respiratory Tract Infections Clinical Trial

Official title:

The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639777
• Other study ID #: 35355/3/22
• Status: Recruiting
• Phase: Phase 4
• Start date: December 6, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2022
• Source: Tanta University
• Contact: Eman A Azzam, M·B·B·CH
• Phone: 0020103743150
• Email: eman162092_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenotonsillectomy
• Communicable Diseases
• Dexmedetomidine
• Infections
• Respiratory Tract Infections

Intervention

Drug:
• Dexmedetomidine group
That will receive intranasal dexmedetomidine (1.5mcg/kg)

Other:
• control group
That will receive the same volume of 2 ml of intranasal normal saline

Locations

Country	Name	City	State
Egypt	Eman Ahmed Azzam	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of peri-operative respiratory adverse effects (PRAE).	All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.	From induction to emergence from general anesthesia.
Secondary	Sedating effects of this drug.	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.	15 and 30 min after sedation
Secondary	Ease of parental separation.	Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor	15 and 30 min after sedation
Secondary	Face mask acceptance.	Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor	15 and 30 min after sedation
Secondary	Hemodynamic stability	hypertension, tachycardia, bradycardia	15 and 30 min after sedation