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
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Condition or disease | Intervention/treatment | Phase |
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Arrhythmia, Cardiac Kidney Cancer Surgery Anesthesia, Local | Drug: Bupivacaine-fentanyl Device: Holter ECG monitor Procedure: Open kidney cancer surgery Procedure: General anesthesia Procedure: Epidural Anaesthesia | Phase 4 |
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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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Active Comparator: General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
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Device: Holter ECG monitor
3-chanel, CM5 leads Procedure: Open kidney cancer surgery Lateral position
Other Names:
Procedure: General anesthesia Other Names:
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Experimental: Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
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Drug: Bupivacaine-fentanyl
Local anesthetic
Other Names:
Device: Holter ECG monitor 3-chanel, CM5 leads Procedure: Open kidney cancer surgery Lateral position
Other Names:
Procedure: General anesthesia Other Names:
Procedure: Epidural Anaesthesia Other Names:
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- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988219
Poland | |
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw | |
Warsaw, Poland, 02-005 |
Principal Investigator: | Karolina Dobronska, MD | I Department of Anaesthesiology and Intensive Care |
Responsible Party: | Karolina Dobrońska, M.D., Medical University of Warsaw |
ClinicalTrials.gov Identifier: | NCT02988219 |
Other Study ID Numbers: |
U/1/2010 |
First Posted: | December 9, 2016 Key Record Dates |
Results First Posted: | April 25, 2017 |
Last Update Posted: | May 30, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
cardiac arrhythmia epidural anesthesia combined anesthesia general anesthesia |
NSS radical nephrectomy extraperitoneal |
Kidney Neoplasms Carcinoma, Renal Cell Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Kidney Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Epinephrine Fentanyl Bupivacaine Anesthetics Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anesthetics, Intravenous |