Autonomous Nervous System Regulated Paediatric Anaesthesia With Dexmedetomidine or Placebo

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern Denmark
• Collaborator: Odense Patient Data Explorative Network
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria

• Children allocated for general anaesthesia in abdominal and urology setup.

• American Association of Anesthesiologists score 1-2.

• Consent from both parents/legal representatives

Exclusion Criteria:

• 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