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

Medical University of Warsaw

Status and phase: Completed; Phase 4

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

Treatments: Device: Holter ECG monitor; Procedure: Open kidney cancer surgery; Procedure: Epidural Anaesthesia; Drug: Bupivacaine-fentanyl; Procedure: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02988219

U/1/2010

Details and patient eligibility

About

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)

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

General anesthesia (G)

Active Comparator group

Description:

Holter ECG monitor General anesthesia Open kidney cancer surgery

Treatment:

Procedure: General anesthesia

Device: Holter ECG monitor

Procedure: Open kidney cancer surgery

Combined general/epidural (G/E)

Experimental group

Description:

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

Treatment:

Procedure: General anesthesia

Device: Holter ECG monitor

Drug: Bupivacaine-fentanyl

Procedure: Epidural Anaesthesia

Procedure: Open kidney cancer surgery