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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

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE December 9, 2016
Results First Submitted Date  ICMJE January 16, 2017
Results First Posted Date  ICMJE April 25, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
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
Change History Complete list of historical versions of study NCT02988219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Official Title  ICMJE Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
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)
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Arrhythmia, Cardiac
  • Kidney Cancer
  • Surgery
  • Anesthesia, Local
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: General anesthesia (G)
    Holter ECG monitor General anesthesia Open kidney cancer surgery
    Interventions:
    • Device: Holter ECG monitor
    • Procedure: Open kidney cancer surgery
    • Procedure: General anesthesia
  • Experimental: Combined general/epidural (G/E)
    Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
    Interventions:
    • Drug: Bupivacaine-fentanyl
    • Device: Holter ECG monitor
    • Procedure: Open kidney cancer surgery
    • Procedure: General anesthesia
    • Procedure: Epidural Anaesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02988219
Other Study ID Numbers  ICMJE U/1/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karolina Dobrońska, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karolina Dobronska, MD I Department of Anaesthesiology and Intensive Care
PRS Account Medical University of Warsaw
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP