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

Phase 4

Recruiting

• Conditions: Respiratory Tract Infections; Dexmedetomidine; Adenotonsillectomy
• Interventions: Other: control group; Drug: Dexmedetomidine group

• Registration Number: NCT05639777
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2022-11-26
• Study First Submitted QC: 2022-11-26
• Status Verified: 2022-12
• Study Start: 2022-12-06
• Study First Posted: 2022-12-06
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	That will receive the same volume of 2 ml of intranasal normal saline
Intranasal	Dexmedetomidine group	That will receive intranasal dexmedetomidine (1.5mcg/kg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hemodynamic stability	15 and 30 min after sedation	hypertension, tachycardia, bradycardia
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

Trial Locations

Locations (1)

Eman Ahmed Azzam; 🇪🇬 Tanta, El-Gharbia, Egypt