drugset / Trial / NCT05785689

Autonomous Nervous System Regulated Paediatric Anaesthesia With Dexmedetomidine or Placebo

NCT05785689 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous

Indications