Autonomic Nervous System Clinical Trial
Official title:
Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement
Verified date | October 2012 |
Source | Larissa University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - elective shoulder surgery - Age 20- 45 years old - ASA I - II Exclusion Criteria: - Coagulopathy disorders - Infection at the puncture site for the interscalene block - Neurologic deficit in the arm that is going to be operated - Allergy to local anesthetics - BMI > 35 - Psychiatric disorders - Patient's refusal - Problems with patient communication - Arrythmia - Ischaemic heart disease - Diabetes mellitus - Thyroid function disorders - Patients with conduction disorders on the ECG - Electrolyte disorders (K+, Na+, Ca++) - Patients on medication that affect the ECG |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Larissa University Hospital | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
Larissa University Hospital |
Greece,
Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. Review. — View Citation
Muzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993
Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. — View Citation
Pomeranz B, Macaulay RJ, Caudill MA, Kutz I, Adam D, Gordon D, Kilborn KM, Barger AC, Shannon DC, Cohen RJ, et al. Assessment of autonomic function in humans by heart rate spectral analysis. Am J Physiol. 1985 Jan;248(1 Pt 2):H151-3. — View Citation
RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. — View Citation
Rogers MC, Battit G, McPeek B, Todd D. Lateralization of sympathetic control of the human sinus node: ECG changes of stellate ganglion block. Anesthesiology. 1978 Feb;48(2):139-41. — View Citation
Schwartz PJ, Locati EH, Moss AJ, Crampton RS, Trazzi R, Ruberti U. Left cardiac sympathetic denervation in the therapy of congenital long QT syndrome. A worldwide report. Circulation. 1991 Aug;84(2):503-11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of interscalene block on Heart Rate Variability (HRV) | The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right. | 1 year | No |
Secondary | Interscalene block and beach chair positioning | Effect of interscalene block on hypotension during beach chair positioning | 2 years | No |
Secondary | Interscalene block and beach chair positioning | Effect of interscalene block on bradycardia during beach chair positioning | 2 years | No |
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