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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05639777
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
5.3
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine group
  • Other: control group
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
Actual Study Start Date :
Dec 6, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intranasal

That will receive intranasal dexmedetomidine (1.5mcg/kg)

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

    		•
    Placebo Comparator: control group

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    3. 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

    4. Hemodynamic stability [15 and 30 min after sedation]

      hypertension, tachycardia, bradycardia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eman Ahmed Azzam Tanta El-Gharbia Egypt 31527

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eman Ahmed Azzam, Resident of Anesthesia, Surgical Intensive Care and Pain Mrdicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05639777
    Other Study ID Numbers:
    • 35355/3/22
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections
    Dexmedetomidine

    Study Results

    No Results Posted as of Dec 7, 2022