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

NCT01212419 | Completed DMC

• 1 other identifier: HREC #28122
• Study Type: observational
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief 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

Eligibility Criteria

• Age: 32 Weeks - 50 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborns \> 32 weeks' gestational age post abdominal surgery

You may qualify if:

• \> 32 weeks' gestational age
• abdominal surgery

You may not qualify if:

• \< 32 weeks' gestational age
• neurologically compromised

Sponsors & Collaborators

• Royal Children's Hospital: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Olischar, MD

  Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 1, 2010

Record last verified: 2010-09