Trial Outcomes & Findings for Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method (NCT NCT02988219)
NCT ID: NCT02988219
Last Updated: 2017-05-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
60 months
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
General Anesthesia (G)
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Combined General/Epidural (G/E)
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
General Anesthesia (G)
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Combined General/Epidural (G/E)
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Baseline characteristics by cohort
| Measure |
General Anesthesia (G)
n=24 Participants
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Combined General/Epidural (G/E)
n=22 Participants
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
59 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
BMI
|
28.14 kg/m^2
STANDARD_DEVIATION 4.84 • n=5 Participants
|
30.04 kg/m^2
STANDARD_DEVIATION 7.01 • n=7 Participants
|
29.29 kg/m^2
STANDARD_DEVIATION 5.99 • n=5 Participants
|
|
ASA
|
2 scores on a scale
n=5 Participants
|
2 scores on a scale
n=7 Participants
|
2 scores on a scale
n=5 Participants
|
|
Type of Surgery
NSS
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Type of Surgery
Nefrectomy
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 monthsThe 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
Outcome measures
| Measure |
General Anesthesia (G)
n=24 Participants
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Combined General/Epidural (G/E)
n=22 Participants
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
|
|---|---|---|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm during surgery · observed
|
2 Participants
|
5 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm before surgery · observed
|
6 Participants
|
6 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm before surgery · not observed
|
18 Participants
|
16 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm during surgery · not observed
|
22 Participants
|
17 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm after surgery · observed
|
5 Participants
|
4 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Tachycardia < 140 bpm after surgery · not observed
|
19 Participants
|
18 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia before surgery · observed
|
3 Participants
|
3 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia before surgery · not observed
|
21 Participants
|
19 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia during surgery · observed
|
14 Participants
|
10 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia during surgery · not observed
|
10 Participants
|
12 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia after surgery · observed
|
6 Participants
|
4 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia after surgery · not observed
|
18 Participants
|
18 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia in the perioperative period · observed
|
16 Participants
|
11 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Bradycardia in the perioperative period · not observed
|
8 Participants
|
11 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s before surgery · observed
|
0 Participants
|
0 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s before surgery · not observed
|
24 Participants
|
22 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s during surgery · observed
|
2 Participants
|
0 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s during surgery · not observed
|
22 Participants
|
22 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s after surgery · observed
|
2 Participants
|
2 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s after surgery · not observed
|
22 Participants
|
20 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s in the perioperative period · observed
|
2 Participants
|
2 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
pause > 2s in the perioperative period · not observed
|
22 Participants
|
20 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE before surgery · observed
|
1 Participants
|
0 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE before surgery · not observed
|
23 Participants
|
22 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE during surgery · observed
|
1 Participants
|
1 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE during surgery · not observed
|
23 Participants
|
21 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE after surgery · observed
|
1 Participants
|
2 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE after surgery · not observed
|
23 Participants
|
20 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE in the perioperativ · observed
|
1 Participants
|
2 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
SVE in the perioperativ · not observed
|
23 Participants
|
20 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE before surgery · observed
|
1 Participants
|
1 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE before surgery · not observed
|
23 Participants
|
21 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE during surgery · observed
|
3 Participants
|
1 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE during surgery · not observed
|
21 Participants
|
21 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE after surgery · observed
|
3 Participants
|
2 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE after surgery · not observed
|
21 Participants
|
20 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE in the perioperative period · observed
|
3 Participants
|
3 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
VE in the perioperative period · not observed
|
21 Participants
|
19 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Additional intervention needed · observed
|
0 Participants
|
0 Participants
|
|
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Additional intervention needed · not observed
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: arrhythmias analysed: bradycardia, pause \> 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)
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
Outcome measures
| Measure |
General Anesthesia (G)
n=24 Participants
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
|
Combined General/Epidural (G/E)
n=22 Participants
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
|
|---|---|---|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia before surgery · observed
|
3 Participants
|
4 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia before surgery · not observed
|
21 Participants
|
18 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia during surgery · observed
|
16 Participants
|
12 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia during surgery · not observed
|
8 Participants
|
10 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia after surgery · observed
|
8 Participants
|
6 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
arrhythmia after surgery · not observed
|
16 Participants
|
16 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s before surgery · observed
|
0 Participants
|
0 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s before surgery · not observed
|
24 Participants
|
22 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s during surgery · observed
|
0 Participants
|
2 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s during surgery · not observed
|
24 Participants
|
20 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s after surgery · observed
|
1 Participants
|
6 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s after surgery · not observed
|
23 Participants
|
16 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s in the perioperative time · observed
|
1 Participants
|
8 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
QTc long > 0.45s in the perioperative time · not observed
|
23 Participants
|
14 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Additional intervention needed · observed
|
0 Participants
|
0 Participants
|
|
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Additional intervention needed · not observed
|
24 Participants
|
22 Participants
|
Adverse Events
General Anesthesia (G)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined General/Epidural (G/E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place