Anesthesia and Cancer Study: Renal Cell Carcinoma

July 20, 2024 updated by: Jin-Tae Kim, Seoul National University Hospital

The Influence of Type of Anesthesia on Recurrence of Renal Cell Carcinoma After Nephrectomy: a Prospective Randomized Controlled Study

This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, TIVA is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.

Study Type

Interventional

Enrollment (Estimated)

562

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients scheduled for elective nephrectomy due to renal cell carcinoma

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy
  • Allergies to anesthetics
  • Palliative surgery
  • Refusal to participate in the study
  • History of diagnosis or surgery for other cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA group
Patients receiving the total intravenous anesthesia using propofol
Drug: Propofol
Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Active Comparator: inhalation group
Patients receiving inhalation anesthesia using sevoflurane or desflurane
Drug: Inhaled General Anesthetics
Sevoflurane or desflurane for induction and maintenance of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five year metastasis-free survival
Time Frame: five year after surgery
five year metastasis-free survival
five year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one year metastasis-free survival
Time Frame: one years after surgery
one year metastasis-free survival
one years after surgery
three year metastasis-free survival
Time Frame: three years after surgery
three year metastasis-free survival
three years after surgery
one year survival
Time Frame: one year after surgery
survival rate regardless of recurrence
one year after surgery
three year survival
Time Frame: three year after surgery
survival rate regardless of recurrence
three year after surgery
five year survival
Time Frame: five year after surgery
survival rate regardless of recurrence
five year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

December 22, 2022

Study Completion (Estimated)

December 22, 2025

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ane-Can Nx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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