Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06218797
• Other study ID #: NDUGIE2023
• Status: Completed
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 1, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric
• Sedation

Intervention

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 2mg/kg 5 cc 20 minute prior to endoscopy. After that routine sedation protocol in our clinic will be applied.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gag reflex	This will be assessed when a vomiting like response will provoked upon introduction of the endoscope.	through endoscopic procedure up to one hour
Secondary	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	through endoscopic procedure up to one hour
Secondary	Depth of sedation	This will be assessed by Ramsay sedation score	During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)
Secondary	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.	2 hours post the procedure