Anesthesia and Cancer Recurrence im Malignant Melanoma

NCT ID: NCT01588847

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.

The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Melanoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

perioperative immunoediting potential predictive biomarkers lymph node dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regional anesthesia

Group Type EXPERIMENTAL

Spinal anesthesia with Bupivacaine hyperbar 0.5 %

Intervention Type PROCEDURE

Spinal anesthesia with Bupivacaine hyperbar 0.5 %

General anesthesia

Group Type ACTIVE_COMPARATOR

General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Intervention Type PROCEDURE

General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal anesthesia with Bupivacaine hyperbar 0.5 %

Spinal anesthesia with Bupivacaine hyperbar 0.5 %

Intervention Type PROCEDURE

General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Regional anesthesia General anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
* Signed informed consent

Exclusion Criteria

* Age \< 18 years
* Female patients who are pregnant or nursing
* Multiple organ failure
* Contraindications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hugo K Van Aken, MD PhD

Role: STUDY_CHAIR

University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy

Münster, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gerhard Brodner, Prof. Dr.

Role: CONTACT

Phone: +49-251-3287-0

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gerhard Brodner, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02-AnIt-11

Identifier Type: -

Identifier Source: org_study_id