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Premedication and Haemodynamics After Spinal Anesthesia

NCT01066247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-07-26

No results posted yet for this study

Summary

Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood pressure fall. As drugs given for premedication may have impact on HRV variables, the investigators would like to determine if pharmacological premedication may modify hemodynamic changes following spinal blockade. Two drugs will be compared - midazolam which is known to lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.

Conditions

  • Hemodynamics After Spinal Anesthesia

Interventions

DRUG

Morphine hydrochloride; Midazolam

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

DRUG

Midazolam

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Radoslaw Owczuk, Ph.D. · Medical University of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Poland

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 NCT01066247 on ClinicalTrials.gov