NCT06218797

Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. In this patient group, the reflex to vomit is common during probe placement. Discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. In fact, this situation can lead to serious complications such as esophageal rupture. Inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients. Therefore, various sedative drugs are used for procedural sedation in pediatric patients. The use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects. Dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. Due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' It possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. Even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. In this regard, it may be a good alternative for procedures like gastrointestinal endoscopy. Based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex. 108 patients will be included in the study. Patients will be divided into 2 groups. * The control group (Group C) * The group receiving nebulized dexmedetomidine (ND) (Group ND).

Conditions

• Pediatric
• Sedation

Interventions

Type	Name	Description
OTHER	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.
DRUG	Nebulized with dexmedetomidine	Patients will be received nebulisation with dexmedetomidine 2mcg/kg 5 cc 20 minute prior to endoscopy. After that routine sedation protocol in our clinic will be applied.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-04-30
• Completion: 2024-08-30
• First posted: 2024-01-23
• Last updated: 2024-10-22

Locations

1 site across 1 country: Turkey (Türkiye)