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Cancer Mortality Affected by the Choice of Anesthetic Drugs?

NCT01418326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3284

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Enlund

    lead OTHER

Principal Investigators

  • Mats Enlund, M.D., Ph.D. · Uppsala University, Centre for Clinical Research-Vasteras

  • Leif Bergkvist, M.D., Ph.D. · Uppsala University, Centre for Clinnical Research-Vasteras

  • Mats Lambe, M.D., Ph.D. · Uppsala University, Regional Oncologic Centre

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418326 on ClinicalTrials.gov