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Autonomous Nervous System Regulated Paediatric Anaesthesia With Dexmedetomidine or Placebo

NCT05785689 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-04-06

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

To reduce postoperative agitation

DRUG

Placebo

Placebo bolus saline

Sponsors & Collaborators

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Line G Larsen, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-10-01
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785689 on ClinicalTrials.gov