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OpenTrials
Completed

NCT Number: NCT01066247

Premedication and Haemodynamics After Spinal Anesthesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Gdansk

Gdansk, 80-211, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • spinal blockade for elective surgery

Exclusion criteria

  • contraindications for spinal anesthesia
  • hypertension
  • heart failure
  • chronic respiratory failure
  • hypersensitivity for midazolam or morphine

Treatment and study plan

Morphine hydrochloride; Midazolam

Drug

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

midazolam

Drug

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Primary outcomes

  1. hemodynamics after spinal anesthesia

    Time frame: one hour

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2010
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.