NCT05641376

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2022-12-07
• Last updated: 2023-04-25

Locations

1 site across 1 country: Egypt