Cancer Mortality Affected by the Choice of Anesthetic Drugs?
|ClinicalTrials.gov Identifier: NCT01418326|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : May 29, 2015
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|
|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|
Sevoflurane exposure for radical cancer surgery
Propofol exposure for cancer surgery
- Survival [ Time Frame: One year from index procedure ]
- Survival [ Time Frame: Five years from index procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418326
|Uppsala University, Centre for Clinical Research-Vasteras|
|Vasteras, Sweden, SE-72189|
|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|