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Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy

Primary Purpose

Emergence Agitation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nebulized Dexmedetomidine
Intravenous Dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA I and II Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion. Exclusion Criteria: Patient's guardian refusal to participate in the study. Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder. Children on sedative or anticonvulsant medication. history of sleep apnea significant organ dysfunction, cardiac dysrhythmia, congenital heart disease Known allergy to the study drugs.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nebulized Dexmedetomidine

Intravenous Dexmedetomidine

Arm Description

Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.

Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.

Outcomes

Primary Outcome Measures

postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.

Secondary Outcome Measures

Postoperative pain
Postoperative pain will be recorded using FLACC scale at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU.
emergence agitation (EA) onset
Emergence agitation onset time was defined as the interval from the extubation to the occurrence.
Emergence Agitation duration
Emergence agitation duration was the time from Emergence agitation onset to its cessation

Full Information

First Posted
November 29, 2022
Last Updated
April 22, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05641376
Brief Title
Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
Official Title
Nebulized Versus Intravenous Dexmedetomidine for Managing Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebulized Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.
Arm Title
Intravenous Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Nebulized Dexmedetomidine
Intervention Description
Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. Treatment will be stopped when the nebulizer began to sputter. At end of nebulizer administration, they will be observed for 30 min before induction of general anaesthesia. then the children will be transferred to the operation room and will receive intravenous (IV) normal saline 0.9% in 10 ml volume over 10 minutes after anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexmedetomidine
Intervention Description
Children will receive nebulized 3 ml of 0.9% normal saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. then the children will be transferred to the operation room and will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.
Primary Outcome Measure Information:
Title
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
Description
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain will be recorded using FLACC scale at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU.
Time Frame
60 minutes
Title
emergence agitation (EA) onset
Description
Emergence agitation onset time was defined as the interval from the extubation to the occurrence.
Time Frame
60 minutes
Title
Emergence Agitation duration
Description
Emergence agitation duration was the time from Emergence agitation onset to its cessation
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I and II Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion. Exclusion Criteria: Patient's guardian refusal to participate in the study. Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder. Children on sedative or anticonvulsant medication. history of sleep apnea significant organ dysfunction, cardiac dysrhythmia, congenital heart disease Known allergy to the study drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Mohammed, M.D.
Phone
01060757593
Email
ahmedfotoh86@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa A hassan, M.D.
Phone
01002953253
Email
shimaa.abbas@med.aun.edu.eg
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy

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