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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Arrhythmia, Cardiac
Kidney Cancer
Surgery
Anesthesia, Local
Interventions Drug: Bupivacaine-fentanyl
Device: Holter ECG monitor
Procedure: Open kidney cancer surgery
Procedure: General anesthesia
Procedure: Epidural Anaesthesia
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title General Anesthesia (G) Combined General/Epidural (G/E)
Hide Arm/Group Description General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
Period Title: Overall Study
Started 25 25
Completed 24 22
Not Completed 1 3
Reason Not Completed
Lack of Efficacy             1             1
Withdrawal by Subject             0             2
Arm/Group Title General Anesthesia (G) Combined General/Epidural (G/E) Total
Hide Arm/Group Description General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  70.8%
20
  90.9%
37
  80.4%
>=65 years
7
  29.2%
2
   9.1%
9
  19.6%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 22 participants 46 participants
61  (8.50) 57  (9.04) 59  (8.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Female
11
  45.8%
10
  45.5%
21
  45.7%
Male
13
  54.2%
12
  54.5%
25
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 24 participants 22 participants 46 participants
24 22 46
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 22 participants 46 participants
28.14  (4.84) 30.04  (7.01) 29.29  (5.99)
[1]
Measure Description: Body Mass Index
ASA   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 24 participants 22 participants 46 participants
2
(1 to 3)
2
(1 to 3)
2
(1 to 3)
[1]
Measure Description:

AMERICAN SOCIETY OF ANESTHESIOLOGISTASA (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM

ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

*The addition of “E” denotes Emergency surgery

Type of Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
NSS
12
  50.0%
17
  77.3%
29
  63.0%
Nefrectomy
12
  50.0%
5
  22.7%
17
  37.0%
1.Primary Outcome
Title Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Anesthesia (G) Combined General/Epidural (G/E)
Hide Arm/Group Description:
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
Tachycardia < 140 bpm before surgery observed
6
  25.0%
6
  27.3%
not observed
18
  75.0%
16
  72.7%
Tachycardia < 140 bpm during surgery observed
2
   8.3%
5
  22.7%
not observed
22
  91.7%
17
  77.3%
Tachycardia < 140 bpm after surgery observed
5
  20.8%
4
  18.2%
not observed
19
  79.2%
18
  81.8%
Bradycardia before surgery observed
3
  12.5%
3
  13.6%
not observed
21
  87.5%
19
  86.4%
Bradycardia during surgery observed
14
  58.3%
10
  45.5%
not observed
10
  41.7%
12
  54.5%
Bradycardia after surgery observed
6
  25.0%
4
  18.2%
not observed
18
  75.0%
18
  81.8%
Bradycardia in the perioperative period observed
16
  66.7%
11
  50.0%
not observed
8
  33.3%
11
  50.0%
pause > 2s before surgery observed
0
   0.0%
0
   0.0%
not observed
24
 100.0%
22
 100.0%
pause > 2s during surgery observed
2
   8.3%
0
   0.0%
not observed
22
  91.7%
22
 100.0%
pause > 2s after surgery observed
2
   8.3%
2
   9.1%
not observed
22
  91.7%
20
  90.9%
pause > 2s in the perioperative period observed
2
   8.3%
2
   9.1%
not observed
22
  91.7%
20
  90.9%
SVE before surgery observed
1
   4.2%
0
   0.0%
not observed
23
  95.8%
22
 100.0%
SVE during surgery observed
1
   4.2%
1
   4.5%
not observed
23
  95.8%
21
  95.5%
SVE after surgery observed
1
   4.2%
2
   9.1%
not observed
23
  95.8%
20
  90.9%
SVE in the perioperativ observed
1
   4.2%
2
   9.1%
not observed
23
  95.8%
20
  90.9%
VE before surgery observed
1
   4.2%
1
   4.5%
not observed
23
  95.8%
21
  95.5%
VE during surgery observed
3
  12.5%
1
   4.5%
not observed
21
  87.5%
21
  95.5%
VE after surgery observed
3
  12.5%
2
   9.1%
not observed
21
  87.5%
20
  90.9%
VE in the perioperative period observed
3
  12.5%
3
  13.6%
not observed
21
  87.5%
19
  86.4%
Additional intervention needed observed
0
   0.0%
0
   0.0%
not observed
24
 100.0%
22
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments Bradycardia during surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3861
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments No bradycardia observed in the perioperative period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2591
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
arrhythmias analysed: bradycardia, pause > 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)
Arm/Group Title General Anesthesia (G) Combined General/Epidural (G/E)
Hide Arm/Group Description:
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
arrhythmia before surgery observed
3
  12.5%
4
  18.2%
not observed
21
  87.5%
18
  81.8%
arrhythmia during surgery observed
16
  66.7%
12
  54.5%
not observed
8
  33.3%
10
  45.5%
arrhythmia after surgery observed
8
  33.3%
6
  27.3%
not observed
16
  66.7%
16
  72.7%
QTc long > 0.45s before surgery observed
0
   0.0%
0
   0.0%
not observed
24
 100.0%
22
 100.0%
QTc long > 0.45s during surgery observed
0
   0.0%
2
   9.1%
not observed
24
 100.0%
20
  90.9%
QTc long > 0.45s after surgery observed
1
   4.2%
6
  27.3%
not observed
23
  95.8%
16
  72.7%
QTc long > 0.45s in the perioperative time observed
1
   4.2%
8
  36.4%
not observed
23
  95.8%
14
  63.6%
Additional intervention needed observed
0
   0.0%
0
   0.0%
not observed
24
 100.0%
22
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments Arrhythmia before surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments arrhythmia during surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments arrhythmia after surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6544
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments long QTc > 0.45s after surgery
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection General Anesthesia (G), Combined General/Epidural (G/E)
Comments long QTc > 0.24 s in the perioperative time
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title General Anesthesia (G) Combined General/Epidural (G/E)
Hide Arm/Group Description General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
All-Cause Mortality
General Anesthesia (G) Combined General/Epidural (G/E)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
General Anesthesia (G) Combined General/Epidural (G/E)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
General Anesthesia (G) Combined General/Epidural (G/E)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Karolina Dobronska
Organization: Warsaw Medical University
Phone: 48 22 502 17 21
EMail: karolinapladzyk@gmail.com
Layout table for additonal information
Responsible Party: Karolina Dobrońska, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02988219     History of Changes
Other Study ID Numbers: U/1/2010
First Submitted: December 6, 2016
First Posted: December 9, 2016
Results First Submitted: January 16, 2017
Results First Posted: April 25, 2017
Last Update Posted: May 30, 2017