Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia

This study is not yet open for participant recruitment.

Verified by Rigshospitalet, Denmark, January 2009

First Received: January 13, 2009 Last Updated: January 16, 2009 History of Changes

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00824876

Purpose

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.

Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anesthesia Breast Cancer Cancer Nausea and Vomiting Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

To investigate orthostatic function, measured by Finapress

Secondary Outcome Measures:

To investigate the occurrence of postsurgery nausea/vomiting

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.

Eligibility

Ages Eligible for Study:	18 Months to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Mammasurgery patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824876

Contacts

Contact: Morten Bundgaard-Nielsen, MD	0045 35452674	morten.bundgaard-nielsen@rh.hosp.dk
Contact: Henrik Kehlet, MD, Ph.d	0045 35454074	henrik.kehlet@rh.hosp.dk

Locations

Denmark
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, Denmark

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Director:

Henrik Kehlet, MD, Ph.D

dept of surgical patophysiology

More Information

No publications provided

Study ID Numbers:	OT after mastectomy
Study First Received:	January 13, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00824876 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:

Mammae cancer patients

Study placed in the following topic categories:

Skin Diseases
Anesthetics
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009