An interventional study of a routine sedation protocol and Nebulized with dexmedetomidine in Pediatric and Sedation, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care
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
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.
Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group
Other: a routine sedation protocol
Nebulisation with dexmedetomidine
Drug: Nebulized with dexmedetomidine
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.
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.
gag reflex
This will be assessed when a vomiting like response will provoked upon introduction of the endoscope.
Time frame: through endoscopic procedure up to one hour
Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure
This will be assessed using an 5-point Likert scale
Time frame: through endoscopic procedure up to one hour
Depth of sedation
This will be assessed by Ramsay sedation score
Time frame: During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)
Adverse effects
This will be reported for any adverse effects such as oxygen desaturation, the need for jaw thrust maneuver or manual ventilation, laryngospasm, vomiting, and shivering.
Time frame: 2 hours post the procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Ondokuz Mayıs University