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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02988219
Enrollment
50
Registered
2016-12-09
Start date
2010-06-30
Completion date
2016-12-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiac, Kidney Cancer, Surgery, Anesthesia, Local

Keywords

cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, NSS, radical nephrectomy, extraperitoneal

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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.

Interventions

Local anesthetic

DEVICEHolter ECG monitor

3-chanel, CM5 leads

PROCEDUREOpen kidney cancer surgery

Lateral position

PROCEDUREGeneral anesthesia

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period60 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

Secondary

MeasureTime frameDescription
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed60 monthsThe 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

Countries

Poland

Participant flow

Participants by arm

ArmCount
General Anesthesia (G)
General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
24
Combined General/Epidural (G/E)
General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
22
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy11
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicCombined General/Epidural (G/E)TotalGeneral Anesthesia (G)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants9 Participants7 Participants
Age, Categorical
Between 18 and 65 years
20 Participants37 Participants17 Participants
Age, Continuous57 years
STANDARD_DEVIATION 9.04
59 years
STANDARD_DEVIATION 8.58
61 years
STANDARD_DEVIATION 8.5
ASA2 scores on a scale2 scores on a scale2 scores on a scale
BMI30.04 kg/m^2
STANDARD_DEVIATION 7.01
29.29 kg/m^2
STANDARD_DEVIATION 5.99
28.14 kg/m^2
STANDARD_DEVIATION 4.84
Region of Enrollment
Poland
22 participants46 participants24 participants
Sex: Female, Male
Female
10 Participants21 Participants11 Participants
Sex: Female, Male
Male
12 Participants25 Participants13 Participants
Type of Surgery
Nefrectomy
5 Participants17 Participants12 Participants
Type of Surgery
NSS
17 Participants29 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 240 / 22
serious
Total, serious adverse events
0 / 240 / 22

Outcome results

Primary

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

Time frame: 60 months

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia after surgeryobserved6 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm before surgerynot observed18 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm during surgeryobserved2 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm during surgerynot observed22 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm after surgeryobserved5 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm after surgerynot observed19 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia before surgeryobserved3 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia before surgerynot observed21 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia during surgeryobserved14 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia during surgerynot observed10 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm before surgeryobserved6 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia after surgerynot observed18 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia in the perioperative periodobserved16 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia in the perioperative periodnot observed8 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s before surgeryobserved0 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s before surgerynot observed24 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s during surgeryobserved2 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s during surgerynot observed22 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s after surgeryobserved2 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s after surgerynot observed22 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s in the perioperative periodobserved2 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s in the perioperative periodnot observed22 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE before surgeryobserved1 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE before surgerynot observed23 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE during surgeryobserved1 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE during surgerynot observed23 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE after surgeryobserved1 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE after surgerynot observed23 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE in the perioperativobserved1 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE in the perioperativnot observed23 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE before surgeryobserved1 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE before surgerynot observed23 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE during surgeryobserved3 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE during surgerynot observed21 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE after surgeryobserved3 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE after surgerynot observed21 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE in the perioperative periodobserved3 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE in the perioperative periodnot observed21 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodAdditional intervention neededobserved0 Participants
General Anesthesia (G)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodAdditional intervention needednot observed24 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE in the perioperative periodnot observed19 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm before surgeryobserved6 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s in the perioperative periodobserved2 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm before surgerynot observed16 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE before surgeryobserved1 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm during surgeryobserved5 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s in the perioperative periodnot observed20 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm during surgerynot observed17 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE after surgerynot observed20 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm after surgeryobserved4 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE before surgeryobserved0 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodTachycardia < 140 bpm after surgerynot observed18 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE before surgerynot observed21 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia before surgeryobserved3 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE before surgerynot observed22 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia before surgerynot observed19 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodAdditional intervention needednot observed22 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia during surgeryobserved10 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE during surgeryobserved1 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia during surgerynot observed12 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE during surgeryobserved1 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia after surgeryobserved4 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE during surgerynot observed21 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia after surgerynot observed18 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE in the perioperative periodobserved3 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia in the perioperative periodobserved11 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE after surgeryobserved2 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodBradycardia in the perioperative periodnot observed11 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE during surgerynot observed21 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s before surgeryobserved0 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE after surgerynot observed20 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s before surgerynot observed22 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodAdditional intervention neededobserved0 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s during surgeryobserved0 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE in the perioperativobserved2 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s during surgerynot observed22 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodVE after surgeryobserved2 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s after surgeryobserved2 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative PeriodSVE in the perioperativnot observed20 Participants
Combined General/Epidural (G/E)Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Periodpause > 2s after surgerynot observed20 Participants
Comparison: Bradycardia during surgeryp-value: 0.3861Chi-squared
Comparison: No bradycardia observed in the perioperative periodp-value: 0.2591Chi-squared
Secondary

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

Time frame: 60 months

Population: arrhythmias analysed: bradycardia, pause \> 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia before surgeryobserved3 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia before surgerynot observed21 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia during surgeryobserved16 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia during surgerynot observed8 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia after surgeryobserved8 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia after surgerynot observed16 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s before surgeryobserved0 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s before surgerynot observed24 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s during surgeryobserved0 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s during surgerynot observed24 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s after surgeryobserved1 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s after surgerynot observed23 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s in the perioperative timeobserved1 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s in the perioperative timenot observed23 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedAdditional intervention neededobserved0 Participants
General Anesthesia (G)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedAdditional intervention needednot observed24 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedAdditional intervention needednot observed22 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia before surgeryobserved4 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s during surgeryobserved2 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia before surgerynot observed18 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s in the perioperative timeobserved8 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia during surgeryobserved12 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s during surgerynot observed20 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia during surgerynot observed10 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedAdditional intervention neededobserved0 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia after surgeryobserved6 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s after surgeryobserved6 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observedarrhythmia after surgerynot observed16 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s in the perioperative timenot observed14 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s before surgeryobserved0 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s after surgerynot observed16 Participants
Combined General/Epidural (G/E)The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias ObservedQTc long > 0.45s before surgerynot observed22 Participants
Comparison: arrhythmia after surgeryp-value: 0.6544Chi-squared
Comparison: Arrhythmia before surgeryp-value: 0.597Chi-squared
Comparison: arrhythmia during surgeryp-value: 0.4Chi-squared
Comparison: long QTc \> 0.45s after surgeryp-value: 0.077Chi-squared
Comparison: long QTc \> 0.24 s in the perioperative timep-value: 0.0174Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026