Anesthesia and Cancer Study: Renal Cell Carcinoma

NCT04503148 | Active Not Recruiting

• 1 other identifier: Ane-Can Nx
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma

Keywords

Anesthesia; Propofol; Inhaled anesthetics; Renal cell carcinoma; Nephrectomy

Outcome Measures

Primary Outcomes (1)

• five year metastasis-free survival

  five year metastasis-free survival

  five year after surgery

Secondary Outcomes (5)

• one year survival

  one year after surgery

• three year survival

  three year after surgery

• one year metastasis-free survival

  one years after surgery

• three year metastasis-free survival

  three years after surgery

• five year survival

  five year after surgery

Study Arms (2)

TIVA group

EXPERIMENTAL

Patients receiving the total intravenous anesthesia using propofol

Drug: Propofol

inhalation group

ACTIVE COMPARATOR

Patients receiving inhalation anesthesia using sevoflurane or desflurane

Drug: Inhaled General Anesthetics

Interventions

Propofol DRUG

Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia

TIVA group

Inhaled General Anesthetics DRUG

Sevoflurane or desflurane for induction and maintenance of anesthesia

inhalation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Propofol; Anesthetics, Inhalation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: A prospective randomized controlled study

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: September 22, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)