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Cancer Mortality Affected by the Choice of Anesthetic Drugs?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418326
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Enlund, Uppsala University

Brief Summary:

Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?

Aim: To retrospectively examine possible associations (Cox Multiple Regression) between survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during surgery, ahead of a prospective randomised controlled trial.

Hypotheses: One- and five-year survival will be significantly higher after radical breast-, colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.

Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical data from 6 303 patients operated on at the three mentioned anatomical locations at the Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these minimum 4 500 operations would be due to cancer. This register is unique, in that it contains both types of anaesthesia. The other register holds survival data (date and cause of death), stored at the Regional Oncologic Center in Uppsala.

The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper file, concomitantly with extraction of details from anaesthesia and surgery, such as the functional classification of each patient (according to American Association of Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss and possible transfusion.

Current knowledge: Different anaesthetics have opposite effects on the immune system and on the DNA. There is a well-established association between the state of the immune system and cancer growth, which in turn will influence survival. There is also an association between DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and anti-oxidative, and it is not genotoxic.

Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in advance of a multi-centre, prospective, randomised, controlled trial.

Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired effects from anaesthesia on survival has strong relevance for the over all cancer treatment.

Condition or disease
Breast Cancer Colo-rectal Cancer Skin Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 3284 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cancer Mortality Affected by the Choice of Anesthetic Drugs?
Study Start Date : November 2010
Primary Completion Date : September 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Sevoflurane exposure for radical cancer surgery
Propofol exposure for cancer surgery

Primary Outcome Measures :
  1. Survival [ Time Frame: One year from index procedure ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: Five years from index procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients operated on for cancer in breast, colo-rectally, or in skin at a single institution from Jan 1, 1998 to Dec 31, 2009.

Inclusion Criteria:

  • Exposed to general anesthesia for surgical removal of cancer in breast, colo-rectally, or in skin

Exclusion Criteria:

  • Paper file unable to find or missing data in anesthetic file or in outcome registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01418326

Uppsala University, Centre for Clinical Research-Vasteras
Vasteras, Sweden, SE-72189
Sponsors and Collaborators
Principal Investigator: Mats Enlund, M.D., Ph.D. Uppsala University, Centre for Clinical Research-Vasteras
Study Director: Leif Bergkvist, M.D., Ph.D. Uppsala University, Centre for Clinnical Research-Vasteras
Study Chair: Mats Lambe, M.D., Ph.D. Uppsala University, Regional Oncologic Centre

Publications of Results:
Responsible Party: Enlund, Associate professor, Uppsala University Identifier: NCT01418326     History of Changes
Other Study ID Numbers: 2008350
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Enlund, Uppsala University:
Cancer - breast

Additional relevant MeSH terms:
Skin Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Central Nervous System Depressants
Physiological Effects of Drugs