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

Not Applicable

Recruiting

• Conditions: Emergence Agitation
• Interventions: Drug: Intravenous Dexmedetomidine; Drug: Nebulized Dexmedetomidine

• Registration Number: NCT05641376
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2023-02-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-22
• Last Update Posted: 2023-04-25
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale	60 minutes	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

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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt