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Clinical trial

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

ID
Name
60757593
Description
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.
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-08-01
Trial end
2023-12-01
Status
Recruiting
Treatment
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.
Arms:
Nebulized Dexmedetomidine
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.
Arms:
Intravenous Dexmedetomidine
Size
120
Primary endpoint
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
60 minutes
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-04-25

1 organization

2 products

1 indication

Organization
Assiut University
Product
Nebulized Dexmedetomidine
Indication
Emergence Agitation
Product
Dexmedetomidine