NCT01066247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 26, 2011

Status Verified

January 1, 2010

Enrollment Period

9 months

First QC Date

February 9, 2010

Last Update Submit

July 25, 2011

Conditions

Hemodynamics After Spinal Anesthesia

Keywords

spinal anesthesiaheart rate variabilitypremedicationheart rateblood pressure

Outcome Measures

Primary Outcomes (1)

  • hemodynamics after spinal anesthesia

    one hour

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Drug: Midazolam

Morphine

ACTIVE COMPARATOR

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Drug: Morphine hydrochloride; Midazolam

Interventions

Morphine hydrochloride; MidazolamDRUG

intramuscular morphine 10 mg given 30 minutes before spinal blockade performing

Morphine
MidazolamDRUG

intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing

Midazolam

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spinal blockade for elective surgery

You may not qualify if:

  • contraindications for spinal anesthesia
  • hypertension
  • heart failure
  • chronic respiratory failure
  • hypersensitivity for midazolam or morphine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Related Publications (4)

  • 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.

    PMID: 18211442RESULT

  • 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.

    PMID: 16571956RESULT

  • 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.

    PMID: 18675744RESULT

  • 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.

    PMID: 15721728RESULT

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Radoslaw Owczuk, Ph.D.

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 26, 2011

Record last verified: 2010-01

Locations

PL(1)