Clinical trial
Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial
Name
NDUGIE2023
Description
This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort
Trial arms
Trial start
2024-01-31
Estimated PCD
2024-02-15
Trial end
2024-04-01
Status
Completed
Treatment
a routine sedation protocol
In this study group, a routine sedation protocol in our clinic will be applied in the endoscopic unit. Premedication will not be given to the patients.
Arms:
Group C
Nebulized with dexmedetomidine
Patients will be received nebulisation with dexmedetomidine 2mg/kg 5 cc 20 minute prior to endoscopy. After that routine sedation protocol in our clinic will be applied.
Arms:
Group ND
Size
108
Primary endpoint
gag reflex
through endoscopic procedure up to one hour
Eligibility criteria
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status I and II
* 2 to 17 years of age,
* Patient undergoing in Upper Gastrointestinal Endoscopy
Exclusion Criteria:
* Patients with heart disease
* Patients with mental-motor retardation
* Patients with abnormal upper respiratory tract
* Patients with a history of asthma
* Patients with upper respiratory tract history in the last 4 weeks
* Patients with severe sleep apnea on polysomnography
* ASA \>III patients
* Patients with drug allergies
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}
Updated at
2024-04-23
1 organization
1 product
2 indications
Organization
Ondokuz Mayıs UniversityIndication
PediatricIndication
Sedation