Autonomous Nervous System Regulated Paediatric Anaesthesia With Dexmedetomidine or Placebo

NCT05785689 | Unknown Phase 4 DMC

• 1 other identifier: Eudract 202200094359
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, double blinded study is to examine in children whether postoperative agitation can be reduced. The main question it aims to answer is Will optimized, monitor guided analgesic treatment and dexmedetomidine reduce postoperative agitation Participants will receive a standard anaesthesia regimen and on top of that, a titrable remifentanil infusion guided via Mdoloris Anastasia nociception index (ANI) monitor will be added. Additionally, the patients will receive either bolus placebo or bolus dexmedetomidine. The postoperative agitation measured via the Richmond agitation and sedation scale (RASS) score, will be compared. Secondary outcome measures including carbon dioxide trends will be made.

Conditions

Postoperative Confusion; Postoperative Delirium; Postoperative Pain, Acute; Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• Richmond Agitation Sedation Scale Score (RASS)

  Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated)

  Once within the first minute at entering operating theatre

• Richmond Agitation Sedation Scale Score (RASS)

  Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated)

  Once within the first minute at entering the postoperative care unit (PACU)

• Richmond Agitation Sedation Scale Score (RASS)

  Nurse evaluation of agitation/sedation on a scale from -5 (deeply sedated) to +4 (highly agitated)

  Every 15. minutes while admitted to postoperative care unit (PACU) and until discharge, within a time frame of maximum 240 minutes

Secondary Outcomes (17)

• Anaesthesia time consumption

  From the minute of induction of anaesthesia minute of extubation, within a time phrame of 180 minutes

• Postoperative care unit (PACU) time consumption

  From the minute of entering PACU area to the minute of discharge from hospital, within a time phrame of 400 minutes

• Total time consumption

  From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes

• Total fentanyl dosage

  From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes

• total remifentanil dosage

  From the minute of induction of anaesthesia to the minute discharge from hospital, within a time phame of 600 minutes

Study Arms (2)

DEX: Bolus dexmedetomidine 0,5 mcg/kg

EXPERIMENTAL

Intravenous infusion during first 10 minutes of anesthesia

Drug: Dexmedetomidine

Placebo (PCB): Bolus isotonic saline

PLACEBO COMPARATOR

Intravenous infusion during first 10 minutes of anesthesia

Drug: Placebo

Interventions

Dexmedetomidine DRUG

To reduce postoperative agitation

Also known as: DEX

DEX: Bolus dexmedetomidine 0,5 mcg/kg

Placebo DRUG

Placebo bolus saline

Also known as: PCB

Placebo (PCB): Bolus isotonic saline

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children allocated for general anaesthesia in abdominal and urology setup.
• American Association of Anesthesiologists (ASA) score 1-2.
• Consent from both parents/legal representatives

You may not qualify if:

• ASA \>2
• Missing consent from both parents/legal representatives.
• Known allergies or intolerances for remifentanil and dexmedetomidine.
• Intubation.
• Non fluently Danish speaking/reading parents/representatives

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Postoperative Complications

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Intervention Hierarchy (Ancestors)

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

Study Officials

• Line G Larsen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Line G Larsen

CONTACT

22671750; line.gry.larsen@rsyd.dk

Nicola G Clausen

CONTACT

65412547; nicola.groes.clausen2@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years
• Access Criteria: Approved by principal investigator

Locations

DK (1)