Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia

July 7, 2009 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Mammasurgery patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To investigate orthostatic function, measured by Finapress

Secondary Outcome Measures

Outcome Measure
To investigate the occurrence of postsurgery nausea/vomiting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Henrik Kehlet, MD, Ph.D, dept of surgical patophysiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OT after mastectomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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