Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

NCT ID: NCT06218797

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-08-30

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).

Conditions

Pediatric; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group C

Control group

Group Type: ACTIVE_COMPARATOR

a routine sedation protocol

Intervention Type: 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 ND

Nebulisation with dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Nebulized with dexmedetomidine

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Nebulized with dexmedetomidine

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Esra Turunc

Study director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra Turunc

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40319232 (View on PubMed)

Other Identifiers

NDUGIE2023

Identifier Type: -

Identifier Source: org_study_id