Effects of Anesthesia on Immunity in Cancer

NCT ID: NCT03514550

Last Updated: 2019-06-03

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-14

Study Completion Date

2019-05-20

Brief Summary

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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.

Detailed Description

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The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.

Conditions

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Surgery Renal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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total intravenous anesthesia

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol will be used for anesthesia during surgery

Epidural block

Intervention Type PROCEDURE

Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia

Volatile anesthesia

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Sevoflurane will be used for anesthesia during surgery

Epidural block

Intervention Type PROCEDURE

Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia

Interventions

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Propofol

Propofol will be used for anesthesia during surgery

Intervention Type DRUG

Sevoflurane

Sevoflurane will be used for anesthesia during surgery

Intervention Type DRUG

Epidural block

Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Surgery for renal cancer
* Signed informed concent

Exclusion Criteria

* Propofol or sevoflurane intolerance
* Contraindications for epidural anesthesia
* Renal failure
* Hepatic failure
* Congestive heart failure
* Previous hemotherapy
* Hematological diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Efremov Sergey

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Onko1

Identifier Type: -

Identifier Source: org_study_id

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