NCT00824876

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

First QC Date

January 13, 2009

Last Update Submit

July 7, 2009

Conditions

Breast Cancer

Keywords

Mammae cancer patients

Outcome Measures

Primary Outcomes (1)

  • To investigate orthostatic function, measured by Finapress

Secondary Outcomes (1)

  • To investigate the occurrence of postsurgery nausea/vomiting

Eligibility Criteria

Age18 Months - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mammasurgery patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Henrik Kehlet, MD, Ph.D

    dept of surgical patophysiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 19, 2009

Study Start

January 1, 2009

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

DK(1)