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

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641376
• Other study ID #: 60757593
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Ahmed A Mohammed, M.D.
• Phone: 01060757593
• Email: ahmedfotoh86[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	emergence agitation (EA) onset	Emergence agitation onset time was defined as the interval from the extubation to the occurrence.	60 minutes
Secondary	Emergence Agitation duration	Emergence agitation duration was the time from Emergence agitation onset to its cessation	60 minutes