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

Phase 4

Completed

• Conditions: Arrhythmia, Cardiac; Surgery; Anesthesia, Local; Kidney Cancer
• Interventions: Drug: Bupivacaine-fentanyl; Procedure: Open kidney cancer surgery; Device: Holter ECG monitor; Procedure: General anesthesia; Procedure: Epidural Anaesthesia

• Registration Number: NCT02988219
• Lead Sponsor: Medical University of Warsaw

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2014-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Results First Submitted: 2017-01-16
• Results First Submitted QC: 2017-03-14
• Status Verified: 2017-04
• Results First Posted: 2017-04-25
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined general/epidural (G/E)	Epidural Anaesthesia	Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
General anesthesia (G)	Open kidney cancer surgery	Holter ECG monitor General anesthesia Open kidney cancer surgery
Combined general/epidural (G/E)	Bupivacaine-fentanyl	Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Combined general/epidural (G/E)	Holter ECG monitor	Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Combined general/epidural (G/E)	Open kidney cancer surgery	Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
General anesthesia (G)	General anesthesia	Holter ECG monitor General anesthesia Open kidney cancer surgery
General anesthesia (G)	Holter ECG monitor	Holter ECG monitor General anesthesia Open kidney cancer surgery
Combined general/epidural (G/E)	General anesthesia	Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

Primary Outcome Measures

Name	Time	Method
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period	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

Secondary Outcome Measures

Name	Time	Method
The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed	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

Trial Locations

Locations (1)

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw; 🇵🇱 Warsaw, Poland