Dexmetomidine in Children Undergoing General Anaesthesia

NCT03923075 | Completed

• 1 other identifier: DEXAINMBCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of dexmedetomidine on the onset of both the general anaesthesia induction and the neuromuscular blockade in children of school age will be investigated. Ten minutes before the induction of general anaesthesia, the first group will receive continuous infusion of dexmedetomidine (DEX group), while the second group will receive normal saline (Placebo group).

Conditions

Anesthesia

Keywords

dexmedetomidine; propofol; rocuronium; TOF; children

Outcome Measures

Primary Outcomes (1)

• Onset of neuromuscular blockade

  Neuromuscular blockade is estimated with TOF acceleromyography, while onset of neuromuscular blockaded is defined as the time needed to achieve TOF=0 after the injection of rocuronium.

  Up to 5 minutes after the injection of rocuronium

Secondary Outcomes (3)

• Onset of anaesthesia induction

  Up to 15 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively

• Number of participants who developed bradycardia

  Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively

• Number of participants who developed hypotension

  Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Drug: dexmedetomidine (Dexmed) solution(100μcg of dexmedetomidine in 50ml N/S 0.9%). given at a bolus dose of 0.5μcg/kg of the dexmedetomidine solution \[that corresponds to the volume (ml) calculated by the type "body weight (Kg)/4 or body weight (Kg) X 0.25". THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY

Drug: Dexmedetomidine

0.9 % saline

PLACEBO COMPARATOR

Drug:0.9 % saline solution (Normal saline) given at a volume (ml) determined by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25" THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY

Other: 0.9% saline

Interventions

Dexmedetomidine DRUG

INFUSION BEFORE INDUCTION OF ANAESTHESIA

Also known as: Dexmed

Dexmedetomidine

0.9% saline OTHER

INFUSION BEFORE INDUCTION OF ANAESTHESIA

Also known as: normal saline

0.9 % saline

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children underoing elective surgery under general anaesthsia
• age 4-12 years old
• ASA I-II

You may not qualify if:

• patient or parent refusal
• Mallampati score\> 3
• BMI\>35
• severe systemic cardiac disease
• neuromuscular disease
• recent respiratory infection
• drug allergy

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (1)

• Kouna N, Matsota P. Effect of Dexmedetomidine on Rocuronium-Induced Neuromuscular Blockade and Intubation Condition in Children: A Randomized Controlled Trial. Paediatr Anaesth. 2025 Dec 20. doi: 10.1002/pan.70098. Online ahead of print.

  PMID: 41420428 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Georgia K Kostopanagiotou

  2nd Department of Anaesthesiology, "Attikon" University Hospital

  STUDY CHAIR

• Paraskevi K Matsota

  2nd Department of Anaesthesiology, "Attikon" University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Anaesthesiology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 22, 2019
• Study Start: May 2, 2019
• Primary Completion: January 20, 2024
• Study Completion: June 12, 2024
• Last Updated: August 14, 2025

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)