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

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

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

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

Intervention / Treatment
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* Drug: Bupivacaine-fentanyl
* Device: Holter ECG monitor
* Procedure: Open kidney cancer surgery
* Procedure: General anesthesia
* Procedure: Epidural Anaesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia (G)<br>Holter ECG monitor General anesthesia Open kidney cancer surgery | Device: Holter ECG monitor<br>* 3-chanel, CM5 leads<br>Procedure: Open kidney cancer surgery<br>* Lateral position<br>* Other names: Extraperitoneal;Procedure: General anesthesia<br> <br> * Other names: Narcosis;|
| Experimental: Combined general/epidural (G/E)<br>Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery | Drug: Bupivacaine-fentanyl<br>* Local anesthetic<br>* Other names: Fentanyl;Device: Holter ECG monitor<br>* 3-chanel, CM5 leads<br>Procedure: Open kidney cancer surgery<br>* Lateral position<br>* Other names: Extraperitoneal;Procedure: General anesthesia<br> <br> * Other names: Narcosis;Procedure: Epidural Anaesthesia<br> <br> * Other names: Epidural catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSS, cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, radical nephrectomy, extraperitoneal