Back to resultsIntranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection
Primary Purpose
Dexmedetomidine, Adenotonsillectomy, Respiratory Tract Infections
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine group
control group
Sponsored by
About this trial
This is an interventional prevention trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria: Children with recent mild URI or asthma. aged from 3 to 10 years ASA Physical Status II, undergoing adenotonsillectomy Exclusion Criteria: 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
Sites / Locations
- Eman Ahmed AzzamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intranasal
control group
Arm Description
That will receive intranasal dexmedetomidine (1.5mcg/kg)
That will receive the same volume of 2 ml of intranasal normal saline
Outcomes
Primary Outcome Measures
The incidence of peri-operative respiratory adverse effects (PRAE).
All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.
Secondary Outcome Measures
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.
Ease of parental separation.
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Face mask acceptance.
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Hemodynamic stability
hypertension, tachycardia, bradycardia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05639777
Brief Title
Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection
Official Title
The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Adenotonsillectomy, Respiratory Tract Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intranasal
Arm Type
Experimental
Arm Description
That will receive intranasal dexmedetomidine (1.5mcg/kg)
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
That will receive the same volume of 2 ml of intranasal normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine group
Other Intervention Name(s)
Precedex
Intervention Description
That will receive intranasal dexmedetomidine (1.5mcg/kg)
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
That will receive the same volume of 2 ml of intranasal normal saline
Primary Outcome Measure Information:
Title
The incidence of peri-operative respiratory adverse effects (PRAE).
Description
All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.
Time Frame
From induction to emergence from general anesthesia.
Secondary Outcome Measure Information:
Title
Sedating effects of this drug.
Description
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.
Time Frame
15 and 30 min after sedation
Title
Ease of parental separation.
Description
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Time Frame
15 and 30 min after sedation
Title
Face mask acceptance.
Description
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Time Frame
15 and 30 min after sedation
Title
Hemodynamic stability
Description
hypertension, tachycardia, bradycardia
Time Frame
15 and 30 min after sedation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with recent mild URI or asthma.
aged from 3 to 10 years
ASA Physical Status II,
undergoing adenotonsillectomy
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman A Azzam, M․B․B․CH
Phone
0020103743150
Email
eman162092_pg@med.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman A Yousef, Professor
Organizational Affiliation
Anesthiology' Surgical Intensive care and Pain Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gehan M Eid, Professor
Organizational Affiliation
Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wail E Messbah, Lecturer
Organizational Affiliation
Anesthiology' Surgical Intensive care and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman Ahmed Azzam
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman A Azzam, MD
Phone
0020103743150
Ext
139
Email
eman162092_pg@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Ayman A Yousef, MD
First Name & Middle Initial & Last Name & Degree
Gehan M Eid, MD
First Name & Middle Initial & Last Name & Degree
Wail E Messbah, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be upon reasonable request from the principle investigator
IPD Sharing Time Frame
For one year after completion of the study
Learn more about this trial
Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection
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