Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

Ondokuz Mayıs University108 enrolled

Overview

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. * The control group (Group C) * The group receiving nebulized dexmedetomidine (ND) (Group ND).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

108

Conditions

Pediatric Sedation

Interventions

a routine sedation protocolOTHER

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.

Nebulized with dexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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