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A randomized study to evaluate whether there is a difference in survival between two different forms of anaesthesia. The study will evaluate patients that are scheduled for a surgery for either breast-, colon- or rectalcancer.

A Randomized, Open-label Study to compare Propofol Anaesthesia with Sevoflurane Anaesthesia in terms of Overall Survival in Patients with Surgical Intervention for either Breast-, Colon- or Rectalcancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002380-25-SE
Enrollment
Unknown
Registered
2013-07-12
Start date
2013-08-16
Completion date
Unknown
Last updated
2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast- or colorectal cancer that will undergo radical surgery for this cancer. During the surgery general aneasthesia with either propofol or sevoflurane will be used. MedDRA version: 14.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignan

Interventions

Pharmaceutical Form: INN or Proposed INN: Sevoflurane CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentration unit: % percent Concentration type: range Concentration number: 0.7-2.6

Sponsors

CKF at Västmanlands hospital Västerås
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Be informed of the nature of the study and have provided written informed consent 2.At least 18 years of age 3.Patient that is scheduled for elective radical breast- or colorectal cancer surgery in general anaesthesia. Radical surgery means that the aim of the surgery is to cure (adjuvant treatment such as chemotherapy and/or radiation therapy seen as part of the curative treatment) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5000

Exclusion criteria

Exclusion criteria: 1. The surgery that is going to be made is an acute surgical procedure 2. The surgery that is going to be made is palliative surgery 3. Known or suspected hypersensitivity to either propofol or sevoflurane or presence of any contraindication according to the substances’ valid SPC. 4. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator (e.g. communicative disturbances (language or intellectual))

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective is to evaluate whether the one- and five-year survival after radical breast-, or colorectal cancer surgery in general anaesthesia is significantly higher in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be a comparison of overall survival using time to event (i.e. death) analysis. ;Timepoint(s) of evaluation of this end point: One year and five year after radical surgery—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable—

Countries

Sweden

Contacts

Public ContactMats Enlund

Mats Enlund

mats.enlund@ltv.se462117 37 75

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026