Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06218797 |
Other study ID # |
NDUGIE2023 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 31, 2024 |
Est. completion date |
April 1, 2024 |
Study information
Verified date |
April 2024 |
Source |
Ondokuz Mayis University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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).