Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824876
• Other study ID #: OT after mastectomy
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: July 7, 2009
• Start date: January 2009

Study information

• Verified date: July 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months to 70 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Denmark	Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate orthostatic function, measured by Finapress
Secondary	To investigate the occurrence of postsurgery nausea/vomiting