Hemodynamics After Spinal AnesthesiaNCT01066247
Premedication and Haemodynamics After Spinal Anesthesia
A study testing Morphine hydrochloride; Midazolam and Midazolam in people with Hemodynamics After Spinal Anesthesia, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamics After Spinal Anesthesia
- What is being tested?
- Morphine hydrochloride; Midazolam and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spinal blockade for elective surgery
Who cannot join
- contraindications for spinal anesthesia
- hypertension
- heart failure
- chronic respiratory failure
- hypersensitivity for midazolam or morphine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia
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.
- Conditions
- Hemodynamics After Spinal Anesthesia
- Being tested
- Morphine hydrochloride; Midazolam, Midazolam
- Keywords
- spinal anesthesia, heart rate variability, premedication, heart rate, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine hydrochloride; MidazolamDrug
intramuscular morphine 10 mg given 30 minutes before spinal blockade performing
MidazolamDrug
intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing Receives: Drug: Midazolam |
| Morphine | Active comparator | intramuscular morphine 10 mg given 30 minutes before spinal blockade performing Receives: Drug: Morphine hydrochloride; Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamics after spinal anesthesia
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemodynamics After Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Investigators
- Radoslaw Owczuk, Ph.D., Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066247
- Sponsor's protocol ID
- GUMed-Ow-001
- Status last verified
- Jan 2010
- First submitted
- 9 Feb 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18211442Hanss 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.
PubMed 16571956Owczuk 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.
PubMed 18675744Hidaka 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.
PubMed 15721728
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01066247
- Acronym / sponsor ID
- GUMed-Ow-001
- Conditions
- Hemodynamics After Spinal Anesthesia
- Keywords
- spinal anesthesia, heart rate variability, premedication, heart rate, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: Midazolamintramuscular midazolam 15 mg given 30 minutes before spinal blockade performing |
| Morphine | Active comparator | Drug: Morphine hydrochloride; Midazolamintramuscular morphine 10 mg given 30 minutes before spinal blockade performing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spinal blockade for elective surgery
Key exclusion criteria (5 listed)
- contraindications for spinal anesthesia
- hypertension
- heart failure
- chronic respiratory failure
- hypersensitivity for midazolam or morphine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine hydrochloride; Midazolamintramuscular morphine 10 mg given 30 minutes before spinal blockade performing | Drug | Morphine |
| Midazolamintramuscular midazolam 15 mg given 30 minutes before spinal blockade performing | Drug | Midazolam |
Primary outcome
hemodynamics after spinal anesthesia
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
- Results publication: PubMed 18211442Hanss 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.
- Results publication: PubMed 16571956Hanss 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.
- Results publication: PubMed 18675744Owczuk 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.
- Results publication: PubMed 15721728Hidaka 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.
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Comparison of the Efficacy of Continuous Metaraminol Infusion Versus Continuous Norepinephrine Infusion for the Prevention of Hypotension During Cesarean Section Under Spinal Anaesthesia. A Randomised Controlled Trial.
Hypotension After Spinal Anesthesia, Hypotension During Cesarean Delivery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radoslaw Owczuk, Ph.D. principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine hydrochloride; Midazolam and Midazolam in people with Hemodynamics After Spinal Anesthesia, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamics after spinal anesthesia (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01066247, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.