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

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ClinicalTrials.gov Identifier: NCT02988219
Recruitment Status : Completed
First Posted : December 9, 2016
Results First Posted : April 25, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Karolina Dobrońska, Medical University of Warsaw

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Arrhythmia, Cardiac Kidney Cancer Surgery Anesthesia, Local Drug: Bupivacaine-fentanyl Device: Holter ECG monitor Procedure: Open kidney cancer surgery Procedure: General anesthesia Procedure: Epidural Anaesthesia Phase 4

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Study Start Date : June 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
 Device: Holter ECG monitor
3-chanel, CM5 leads

Procedure: Open kidney cancer surgery
Lateral position
Other Names:
  • nephron sparing surgery (NSS)
  • Radical nephrectomy
  • Extraperitoneal

Procedure: General anesthesia
Other Names:
  • Intubation
  • Fentanyl
  • Narcosis
Experimental: Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
 Drug: Bupivacaine-fentanyl
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine
  • Astra Zeneca
  • Bupivacaine-epinephrine
  • Fentanyl

Device: Holter ECG monitor
3-chanel, CM5 leads

Procedure: Open kidney cancer surgery
Lateral position
Other Names:
  • nephron sparing surgery (NSS)
  • Radical nephrectomy
  • Extraperitoneal

Procedure: General anesthesia
Other Names:
  • Intubation
  • Fentanyl
  • Narcosis

Procedure: Epidural Anaesthesia
Other Names:
  • Bupivacaine
  • Epidural catheter


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988219


Locations
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Poland
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, Poland, 02-005
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Karolina Dobronska, MD I Department of Anaesthesiology and Intensive Care
More Information
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Responsible Party: Karolina Dobrońska, M.D., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02988219     History of Changes
Other Study ID Numbers: U/1/2010
First Posted: December 9, 2016    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karolina Dobrońska, Medical University of Warsaw:
cardiac arrhythmia
epidural anesthesia
combined anesthesia
general anesthesia
 NSS
radical nephrectomy
extraperitoneal

Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Arrhythmias, Cardiac
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Anesthetics
Bupivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General