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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639777
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Eman Ahmed Azzam, 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.

Condition or disease Intervention/treatment Phase
Dexmedetomidine Adenotonsillectomy Respiratory Tract Infections 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 6, 2022
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : May 15, 2023

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. The incidence of peri-operative respiratory adverse effects (PRAE). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 15 and 30 min after sedation ]
    hypertension, tachycardia, bradycardia



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639777


Contacts
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Contact: Eman A Azzam, M․B․B․CH 0020103743150 eman162092_pg@med.tanta.edu.eg

Locations
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Egypt
Eman Ahmed Azzam Recruiting
Tanta, El-Gharbia, Egypt, 31527
Contact: Eman A Azzam, MD    0020103743150 ext 139    eman162092_pg@med.tanta.edu.eg   
Sub-Investigator: Ayman A Yousef, MD         
Sub-Investigator: Gehan M Eid, MD         
Sub-Investigator: Wail E Messbah, MD         
Sponsors and Collaborators
Tanta University
Investigators
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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
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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: December 6, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be upon reasonable request from the principle investigator
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: For one year after completion of the study

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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:
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Infections
Communicable Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action