Premedication and Haemodynamics After Spinal Anesthesia

NCT ID: NCT01066247

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodynamics After Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Midazolam

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Morphine

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Group Type ACTIVE_COMPARATOR

Morphine hydrochloride; Midazolam

Intervention Type DRUG

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Interventions

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Morphine hydrochloride; Midazolam

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Intervention Type DRUG

Midazolam

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* spinal blockade for elective surgery

Exclusion Criteria

* contraindications for spinal anesthesia
* hypertension
* heart failure
* chronic respiratory failure
* hypersensitivity for midazolam or morphine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Gdansk

Principal Investigators

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Radoslaw Owczuk, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type RESULT
PMID: 18211442 (View on PubMed)

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.

Reference Type RESULT
PMID: 16571956 (View on PubMed)

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.

Reference Type RESULT
PMID: 18675744 (View on PubMed)

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.

Reference Type RESULT
PMID: 15721728 (View on PubMed)

Other Identifiers

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GUMed-Ow-001

Identifier Type: -

Identifier Source: org_study_id

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