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Premedication and Haemodynamics After Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT01066247
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Medical University of Gdansk

February 9, 2010
February 10, 2010
July 26, 2011
September 2009
June 2010   (Final data collection date for primary outcome measure)
hemodynamics after spinal anesthesia [ Time Frame: one hour ]
Same as current
Complete list of historical versions of study NCT01066247 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Premedication and Haemodynamics After Spinal Anesthesia
The Influence of HRV-changing Premedication on Hemodynamic Parameters 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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Hemodynamics After Spinal Anesthesia
  • 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
  • Active Comparator: Midazolam
    intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
    Intervention: Drug: Midazolam
  • Active Comparator: Morphine
    intramuscular morphine 10 mg given 30 minutes before spinal blockade performing
    Intervention: Drug: Morphine hydrochloride; Midazolam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • spinal blockade for elective surgery

Exclusion Criteria:

  • contraindications for spinal anesthesia
  • hypertension
  • heart failure
  • chronic respiratory failure
  • hypersensitivity for midazolam or morphine
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01066247
GUMed-Ow-001
No
Not Provided
Not Provided
Dr Radoslaw Owczuk, Medical University of Gdansk
Medical University of Gdansk
Not Provided
Principal Investigator: Radoslaw Owczuk, Ph.D. Medical University of Gdansk
Medical University of Gdansk
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP