Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-12-31

Brief Summary

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This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)

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Detailed Description

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Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled.

A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM).

Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.

Conditions

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Arrhythmia, Cardiac Kidney Cancer Surgery Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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General anesthesia (G)

Holter ECG monitor General anesthesia Open kidney cancer surgery

Group Type ACTIVE_COMPARATOR

Holter ECG monitor

Intervention Type DEVICE

3-chanel, CM5 leads

Open kidney cancer surgery

Intervention Type PROCEDURE

Lateral position

General anesthesia

Intervention Type PROCEDURE

Combined general/epidural (G/E)

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

Group Type EXPERIMENTAL

Bupivacaine-fentanyl

Intervention Type DRUG

Local anesthetic

Holter ECG monitor

Intervention Type DEVICE

3-chanel, CM5 leads

Open kidney cancer surgery

Intervention Type PROCEDURE

Lateral position

General anesthesia

Intervention Type PROCEDURE

Epidural Anaesthesia

Intervention Type PROCEDURE

Interventions

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Bupivacaine-fentanyl

Local anesthetic

Intervention Type DRUG

Holter ECG monitor

3-chanel, CM5 leads

Intervention Type DEVICE

Open kidney cancer surgery

Lateral position

Intervention Type PROCEDURE

General anesthesia

Intervention Type PROCEDURE

Epidural Anaesthesia

Intervention Type PROCEDURE

Other Intervention Names

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Marcaine Sensorcaine Astra Zeneca Bupivacaine-epinephrine Fentanyl nephron sparing surgery (NSS) Radical nephrectomy Extraperitoneal Intubation Fentanyl Narcosis Bupivacaine Epidural catheter

Eligibility Criteria

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Inclusion Criteria

* Open renal cell carcinoma surgery, lateral position
* American Society of Anesthesiologists (ASA) physical grade I-III
* No history of cardiac arrhythmias
* Informed consent

Exclusion Criteria

* Pregnancy and breast feeding
* Contraindications for epidural anesthesia
* Laparoscopic or robotic surgery
* Suspected difficult intubation (ex. fibroscopic)
* Chest deformations
* Prior cardiac/thoracic surgery
* Cardiac insufficiency
* abnormal ECG before the surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No