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Premedication and Haemodynamics After Spinal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066247
First Posted: February 10, 2010
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Gdansk
  Purpose
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.

Condition Intervention
Hemodynamics After Spinal Anesthesia Drug: Morphine hydrochloride; Midazolam Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • hemodynamics after spinal anesthesia [ Time Frame: one hour ]

Estimated Enrollment: 60
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Midazolam
intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
Drug: Midazolam
intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
Active Comparator: Morphine
intramuscular morphine 10 mg given 30 minutes before spinal blockade performing
Drug: Morphine hydrochloride; Midazolam
intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spinal blockade for elective surgery

Exclusion Criteria:

  • contraindications for spinal anesthesia
  • hypertension
  • heart failure
  • chronic respiratory failure
  • hypersensitivity for midazolam or morphine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066247


Locations
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Principal Investigator: Radoslaw Owczuk, Ph.D. Medical University of Gdansk
  More Information

Publications:
Responsible Party: Dr Radoslaw Owczuk, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01066247     History of Changes
Other Study ID Numbers: GUMed-Ow-001
First Submitted: February 9, 2010
First Posted: February 10, 2010
Last Update Posted: July 26, 2011
Last Verified: January 2010

Keywords provided by Medical University of Gdansk:
spinal anesthesia
heart rate variability
premedication
heart rate
blood pressure

Additional relevant MeSH terms:
Anesthetics
Midazolam
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action