Premedication and Haemodynamics After Spinal Anesthesia

This study has been completed.
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01066247
First received: February 9, 2010
Last updated: July 25, 2011
Last verified: January 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 9, 2010
Last Updated: July 25, 2011
Health Authority: Poland: Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotics

ClinicalTrials.gov processed this record on July 23, 2014