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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Nebulized Dexmedetomidine; Drug: Intravenous Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Mohammed, M.D.; Phone Number: 01060757593; Email: ahmedfotoh86@aun.edu.eg
• Study Contact Backup: Name: Shimaa A hassan, M.D.; Phone Number: 01002953253; Email: shimaa.abbas@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nebulized Dexmedetomidine; Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.	Drug: Nebulized Dexmedetomidine; 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.
Active Comparator: Intravenous Dexmedetomidine; Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.	Drug: Intravenous Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 60757593

Drug and device information, study documents

• 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