NCT02988219

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Conditions

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

Interventions

Type	Name	Description
DRUG	Bupivacaine-fentanyl	Local anesthetic
DEVICE	Holter ECG monitor	3-chanel, CM5 leads
PROCEDURE	Open kidney cancer surgery	Lateral position
PROCEDURE	General anesthesia
PROCEDURE	Epidural Anaesthesia

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2016-12-09
• Last updated: 2017-05-30
• Results posted: 2017-04-25

Locations

1 site across 1 country: Poland