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Emergence Agitation in Paediatric Day Care Surgery

NCT06571890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-08-26

No results posted yet for this study

Summary

Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.

In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).

93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.

Conditions

  • Postoperative Delirium
  • Postoperative Agitation
  • Anesthesia
  • Pain Monitoring
  • Heart Rate Variability
  • Narcotrend
  • Mdoloris
  • Anesthesia Nociception Index

Interventions

DEVICE

Narcotrend bispectral index anaesthesia monitor

A bispectral index anaesthesia monitor collects simplified EEG via forehead electrodes and displays an index of 0-100, where an index of 40-60 is considered optimal

DEVICE

Mdoloris Anaesthesia Nociception Monitor

A heart rate variability-based nociception monitor collects ECG-signal from electrodes on the patient's chest and displays an index of 0-100 where an index below 50 is considered nociceptive.

Sponsors & Collaborators

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Line Gry Larsen · Anaeshtesiologic Intensive Ward V, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2020-06-12
Completion
2020-09-30

Countries

  • Denmark

Study Locations

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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 NCT06571890 on ClinicalTrials.gov