Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

NCT06218797 | Completed

• 1 other identifier: NDUGIE2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric; Sedation

Keywords

Pediatric; Gastrointestinal endoscopy; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure

  through endoscopic procedure up to one hour

• Depth of sedation

  During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)

• Adverse effects

  2 hours post the procedure

Study Arms (2)

Group C

ACTIVE COMPARATOR

Control group

Other: a routine sedation protocol

Group ND

ACTIVE COMPARATOR

Nebulisation with dexmedetomidine

Drug: Nebulized with dexmedetomidine

Interventions

a routine sedation protocol OTHER

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.

Group C

Nebulized with dexmedetomidine DRUG

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.

Group ND

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I and II
• to 17 years of age,
• Patient undergoing in Upper Gastrointestinal Endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (1)

• Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.

  PMID: 40319232 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Esra Turunc

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 23, 2024
• Study Start: January 31, 2024
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)