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

April 25, 2017 updated by: Karolina Dobrońska, Medical University of Warsaw

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-005
        • I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
Procedure: General anesthesia
Other Names:
  • Fentanyl
  • Intubation
  • Narcosis
Device: Holter ECG monitor
3-chanel, CM5 leads
Procedure: Open kidney cancer surgery
Lateral position
Other Names:
  • nephron sparing surgery (NSS)
  • Radical nephrectomy
  • Extraperitoneal
EXPERIMENTAL: Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Procedure: General anesthesia
Other Names:
  • Fentanyl
  • Intubation
  • Narcosis
Device: Holter ECG monitor
3-chanel, CM5 leads
Procedure: Open kidney cancer surgery
Lateral position
Other Names:
  • nephron sparing surgery (NSS)
  • Radical nephrectomy
  • Extraperitoneal
Drug: Bupivacaine-fentanyl
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine
  • Fentanyl
  • Astra Zeneca
  • Bupivacaine-epinephrine
Procedure: Epidural Anaesthesia
Other Names:
  • Bupivacaine
  • Epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Time Frame: 60 months

The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them

Arrhythmias observed:

tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Time Frame: 60 months
The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U/1/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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