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

NCT05639777 | Unknown Phase 4

• 1 other identifier: 35355/3/22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Adenotonsillectomy; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sedating effects of this drug.

  15 and 30 min after sedation

• Ease of parental separation.

  15 and 30 min after sedation

• Face mask acceptance.

  15 and 30 min after sedation

• Hemodynamic stability

  15 and 30 min after sedation

Study Arms (2)

Intranasal

EXPERIMENTAL

That will receive intranasal dexmedetomidine (1.5mcg/kg)

Drug: Dexmedetomidine group

control group

PLACEBO COMPARATOR

That will receive the same volume of 2 ml of intranasal normal saline

Other: control group

Interventions

Dexmedetomidine group DRUG

That will receive intranasal dexmedetomidine (1.5mcg/kg)

Also known as: Precedex

Intranasal

control group OTHER

That will receive the same volume of 2 ml of intranasal normal saline

control group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with recent mild URI or asthma.
• aged from 3 to 10 years
• ASA Physical Status II,
• undergoing adenotonsillectomy

You may not qualify if:

• Parental refusal of participation
• Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
• Lower respiratory tract infection
• Congenital heart diseases
• Known hypersensitivity to specific anesthetic agent
• Liver or renal disease

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Eman Ahmed Azzam

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Dexmedetomidine; Control Groups

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayman A Yousef, Professor

  Anesthiology' Surgical Intensive care and Pain Medicine

  PRINCIPAL INVESTIGATOR

• Gehan M Eid, Professor

  Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine

  PRINCIPAL INVESTIGATOR

• Wail E Messbah, Lecturer

  Anesthiology' Surgical Intensive care and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman A Azzam, M․B․B․CH

CONTACT

0020103743150; eman162092_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Mrdicine

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: December 6, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For one year after completion of the study

Locations

EG (1)