Clinical trial NCT06218797: Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients
Official title: Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric
Sedation
Keywords: Pediatric
Gastrointestinal endoscopy
Dexmedetomidine
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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

Primary outcomes:
measure: gag reflex
timeFrame: through endoscopic procedure up to one hour
Secondary outcomes:
measure: Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure
timeFrame: through endoscopic procedure up to one hour
measure: Depth of sedation
timeFrame: During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)
measure: Adverse effects
timeFrame: 2 hours post the procedure
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Esra Turunc
role: STUDY_DIRECTOR
References: