Clinical trial NCT02988219: Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Official title: Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia, Cardiac
Kidney Cancer
Surgery
Anesthesia, Local
Keywords: cardiac arrhythmia
epidural anesthesia
combined anesthesia
general anesthesia
NSS
radical nephrectomy
extraperitoneal
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
timeFrame: 60 months
Secondary outcomes:
measure: The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
timeFrame: 60 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Study officials:
affiliation: I Department of Anaesthesiology and Intensive Care
name: Karolina Dobronska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobronska K, Jureczko L, Kowalczyk R, Dobronski P, Trzebicki J. Open kidney cancer surgery and perioperative cardiac arrhythmias. Cent European J Urol. 2020;73(4):432-439. doi: 10.5173/ceju.2020.1734. Epub 2020 Nov 2.