Clinical trial NCT01066247: Premedication and Haemodynamics After Spinal Anesthesia
Official title: The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics After Spinal Anesthesia
Keywords: spinal anesthesia
heart rate variability
premedication
heart rate
blood pressure
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: hemodynamics after spinal anesthesia
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Medical University of Gdansk
name: Radoslaw Owczuk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanss R, Renner J, Ilies C, Moikow L, Buell O, Steinfath M, Scholz J, Bein B. Does heart rate variability predict hypotension and bradycardia after induction of general anaesthesia in high risk cardiovascular patients? Anaesthesia. 2008 Feb;63(2):129-35. doi: 10.1111/j.1365-2044.2007.05321.x.
citation: Hanss R, Bein B, Francksen H, Scherkl W, Bauer M, Doerges V, Steinfath M, Scholz J, Tonner PH. Heart rate variability-guided prophylactic treatment of severe hypotension after subarachnoid block for elective cesarean delivery. Anesthesiology. 2006 Apr;104(4):635-43. doi: 10.1097/00000542-200604000-00005.
citation: Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010.
citation: Hidaka S, Kawamoto M, Kurita S, Yuge O. Comparison of the effects of propofol and midazolam on the cardiovascular autonomic nervous system during combined spinal and epidural anesthesia. J Clin Anesth. 2005 Feb;17(1):36-43. doi: 10.1016/j.jclinane.2004.03.012.