Anesthesia and Cancer Study: Renal Cell Carcinoma

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04503148

Collaborator

(none)

562

Enrollment

Location

Arms

57.3

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: Propofol Drug: Inhaled General Anesthetics	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

562 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective randomized controlled studyA prospective randomized controlled study

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 22, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

one year metastasis-free survival [one years after surgery]
one year metastasis-free survival

Secondary Outcome Measures

three year metastasis-free survival [three years after surgery]
three year metastasis-free survival
one year survival [one year after surgery]
survival rate regardless of recurrence
three year survival [three year after surgery]
survival rate regardless of recurrence