Abdominal SurgeryNCT00222391
Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability
An observational study of Abdominal Surgery and Abdominothoracic Surgery, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic activity in surgical patients. The study investigates whether a segmental sympathetic block can be determined and can be correlated to level of the sensoric blockade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery, Abdominothoracic Surgery
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Jan 2006
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery
- combined anesthesia with thoracic epidural anesthesia 8 (Th6-9
- Body-mass-index < 30
Who cannot join
- Fever, Hypothermia, SIRS
- Microangiopathy
- Neuropathy
- Sensomotoric deficits
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesia and Intensive Care, University Hospital Muenster
Münster, D-48149
About this study
Official title: Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability in Surgical Patients
The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic activity in surgical patients. The study investigates whether a segmental sympathetic block can be determined and can be correlated to level of the sensoric blockade.
- Conditions
- Abdominal Surgery, Abdominothoracic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic parameters
Secondary outcomes (2)
Level of sensoric block
skin temperature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Freise, MD, Principal investigator, Department of Anesthesiology and Intensive Care, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222391
- Sponsor's protocol ID
- 01-Anast-04
- Status last verified
- Mar 2006
- First submitted
- 20 Sep 2005
- Last updated
- 7 Jan 2009
- Results posted
- No
Publications
Freise H, Meissner A, Lauer S, Ellger B, Radke R, Bruewer M, Brodner G, Van Aken HK, Sielenkamper AW, Fischer LG. Thoracic epidural analgesia with low concentration of bupivacaine induces thoracic and lumbar sympathetic block: a randomized, double-blind clinical trial. Anesthesiology. 2008 Dec;109(6):1107-12. doi: 10.1097/ALN.0b013e31818db16c.
PubMed 19034108
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability in Surgical Patients
- ClinicalTrials.gov ID
- NCT00222391
- Acronym / sponsor ID
- 01-Anast-04
- Conditions
- Abdominal Surgery, Abdominothoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Jan 2006
- First posted
- 22 Sep 2005 (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.
The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic activity in surgical patients. The study investigates whether a segmental sympathetic block can be determined and can be correlated to level of the sensoric blockade.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective surgery
- combined anesthesia with thoracic epidural anesthesia 8 (Th6-9
- Body-mass-index < 30
Key exclusion criteria (4 listed)
- Fever, Hypothermia, SIRS
- Microangiopathy
- Neuropathy
- Sensomotoric deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemodynamic parameters
2 secondary outcomes
Level of sensoric block
skin temperature
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 7 Jan 2009.
- Results publication: PubMed 19034108Freise H, Meissner A, Lauer S, Ellger B, Radke R, Bruewer M, Brodner G, Van Aken HK, Sielenkamper AW, Fischer LG. Thoracic epidural analgesia with low concentration of bupivacaine induces thoracic and lumbar sympathetic block: a randomized, double-blind clinical trial. Anesthesiology. 2008 Dec;109(6):1107-12. doi: 10.1097/ALN.0b013e31818db16c.
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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.
Henrik Freise, MD principal investigator
Department of Anesthesiology and Intensive Care, University Hospital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery and Abdominothoracic Surgery, run by University Hospital Muenster at 1 site in Germany.
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 3 inclusion and 4 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 7 Jan 2009. 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 Germany. 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?
Hemodynamic parameters. 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 NCT00222391, which also lists 1 linked publication.
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 7 Jan 2009.