Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Primary Purpose
Arrhythmia, Cardiac, Kidney Cancer, Surgery
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Bupivacaine-fentanyl
Holter ECG monitor
Open kidney cancer surgery
General anesthesia
Epidural Anaesthesia
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia, Cardiac focused on measuring cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, NSS, radical nephrectomy, extraperitoneal
Eligibility 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
Sites / Locations
- I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General anesthesia (G)
Combined general/epidural (G/E)
Arm Description
Holter ECG monitor General anesthesia Open kidney cancer surgery
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Outcomes
Primary Outcome Measures
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
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
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
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
Full Information
NCT ID
NCT02988219
First Posted
December 6, 2016
Last Updated
April 25, 2017
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT02988219
Brief Title
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Official Title
Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Cardiac, Kidney Cancer, Surgery, Anesthesia, Local
Keywords
cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, NSS, radical nephrectomy, extraperitoneal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia (G)
Arm Type
Active Comparator
Arm Description
Holter ECG monitor General anesthesia Open kidney cancer surgery
Arm Title
Combined general/epidural (G/E)
Arm Type
Experimental
Arm Description
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl
Other Intervention Name(s)
Marcaine, Sensorcaine, Astra Zeneca, Bupivacaine-epinephrine, Fentanyl
Intervention Description
Local anesthetic
Intervention Type
Device
Intervention Name(s)
Holter ECG monitor
Intervention Description
3-chanel, CM5 leads
Intervention Type
Procedure
Intervention Name(s)
Open kidney cancer surgery
Other Intervention Name(s)
nephron sparing surgery (NSS), Radical nephrectomy, Extraperitoneal
Intervention Description
Lateral position
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Other Intervention Name(s)
Intubation, Fentanyl, Narcosis
Intervention Type
Procedure
Intervention Name(s)
Epidural Anaesthesia
Other Intervention Name(s)
Bupivacaine, Epidural catheter
Primary Outcome Measure Information:
Title
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Description
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
Time Frame
60 months
Secondary Outcome Measure Information:
Title
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Description
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
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
Organizational Affiliation
I Department of Anaesthesiology and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33552568
Citation
Dobronska K, Jureczko L, Kowalczyk R, Dobronski P, Trzebicki J. Open kidney cancer surgery and perioperative cardiac arrhythmias. Cent European J Urol. 2020;73(4):432-439. doi: 10.5173/ceju.2020.1734. Epub 2020 Nov 2.
Results Reference
derived
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Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
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