NCT03514550

Brief Summary

The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 surgery

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

April 13, 2018

Last Update Submit

May 31, 2019

Conditions

SurgeryRenal Cancer

Outcome Measures

Primary Outcomes (1)

  • CD 16

    NK cells expression of CD16 receptor

    postoperative day 1

Secondary Outcomes (8)

  • CD45

    Baseline, end of surgery, postoperative days 1, 3-4, 7

  • CD3

    Baseline, end of surgery, postoperative days 1, 3-4, 7

  • CD19

    Baseline, end of surgery, postoperative days 1, 3-4, 7

  • CD4

    Baseline, end of surgery, postoperative days 1, 3-4, 7

  • CD8

    Baseline, end of surgery, postoperative days 1, 3-4, 7

  • +3 more secondary outcomes

Study Arms (2)

total intravenous anesthesia

EXPERIMENTAL

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia

Drug: PropofolProcedure: Epidural block

Volatile anesthesia

ACTIVE COMPARATOR

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia

Drug: SevofluraneProcedure: Epidural block

Interventions

PropofolDRUG

Propofol will be used for anesthesia during surgery

total intravenous anesthesia
SevofluraneDRUG

Sevoflurane will be used for anesthesia during surgery

Volatile anesthesia
Epidural blockPROCEDURE

Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia

Volatile anesthesiatotal intravenous anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery for renal cancer
  • Signed informed concent

You may not qualify if:

  • Propofol or sevoflurane intolerance
  • Contraindications for epidural anesthesia
  • Renal failure
  • Hepatic failure
  • Congestive heart failure
  • Previous hemotherapy
  • Hematological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

PropofolSevofluraneAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 2, 2018

Study Start

May 14, 2018

Primary Completion

April 1, 2019

Study Completion

May 20, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Locations

RU(1)