Breast CancerNCT00824876
Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia
An observational study of Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients. The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery. Read more about this study
- Who is it for?
- Ages 18 months to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to not given
- 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 months to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mammasurgery patients
Who may be able to join
- Patients having performed elective breast surgery
- Age between 18 and 70 years
- Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol
Who cannot join
- Patients who do not understand or speak Danish
- Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol
- ASA > II
- Pregnant or breastfeeding
- Known to have Renal disease
- Known to have Psychiatric disorder (not considering the use of SSRI antidepressive)
Show all 11Show fewer
- Need for crash induction or prone position
- Oesophageal varicoses
- Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus
- Coarctation or aneurism in the proximal Aorta
- Severe bleeding disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen
About this study
The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients.
The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery.
Read the detailed description
It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting.
With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.
- Conditions
- Breast Cancer
- Keywords
- Mammae cancer patients
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate orthostatic function, measured by Finapress
Secondary outcomes (1)
To investigate the occurrence of postsurgery nausea/vomiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Kehlet, MD, Ph.D, Study director, dept of surgical patophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824876
- Sponsor's protocol ID
- OT after mastectomy
- Status last verified
- Jul 2009
- First submitted
- 13 Jan 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia
- ClinicalTrials.gov ID
- NCT00824876
- Acronym / sponsor ID
- OT after mastectomy
- Conditions
- Breast Cancer
- Keywords
- Mammae cancer patients
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 19 Jan 2009 (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 investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients.
The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery.
Detailed description
It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting.
With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mammasurgery patients
Key inclusion criteria (3 listed)
- Patients having performed elective breast surgery
- Age between 18 and 70 years
- Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol
Key exclusion criteria (11 listed)
- Patients who do not understand or speak Danish
- Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol
- ASA > II
- Pregnant or breastfeeding
- Known to have Renal disease
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
To investigate orthostatic function, measured by Finapress
1 secondary outcome
To investigate the occurrence of postsurgery nausea/vomiting
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 8 Jul 2009.
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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 Kehlet, MD, Ph.D study director
dept of surgical patophysiology
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 Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 11 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 8 Jul 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 Denmark. 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?
To investigate orthostatic function, measured by Finapress. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2009.