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SWC on aEEG in Post-surgical Neonates on Morphine and Midazolam

NCT01212419 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2010-10-01

No results posted yet for this study

Summary

Objectives: Sleep characteristics have been used for prediction of neuro-developmental outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the development of SWC in newborns \> 32 weeks' gestational age after major non-cardiac surgery.

Study design: This prospective aEEG study included infants \> 32+0 weeks' gestation admitted to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC and the maximum levels of morphine and midazolam as predictors of time to SWC were then assessed.

Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of time to SWC.

Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was observed on aEEG in neonates \> 32 weeks' gestational age soon after major non-cardiac surgery. The main type of aEEG background pattern was not affected by the maximum dose of either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always drug related.

Conditions

  • Neurology
  • Newborn
  • Analgesia
  • Sedation
  • Surgery

Sponsors & Collaborators

  • Royal Children's Hospital

    lead OTHER

Principal Investigators

  • Monika Olischar, MD · Royal Children's Hospital

Eligibility

Min Age
32 Weeks
Max Age
50 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

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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 NCT01212419 on ClinicalTrials.gov