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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988219
• Other study ID #: U/1/2010
• Status: Recruiting
• Phase: Phase 4
• First received: December 6, 2016
• Last updated: December 8, 2016
• Start date: June 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Medical University of Warsaw
• Contact: Karolina Dobronska, MD
• Phone: 48 501 323 534
• Email: karolinapladzyk[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anesthesia, Local
• Arrhythmia, Cardiac
• Arrhythmias, Cardiac
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Surgery

Intervention

Procedure:
• Epidural anesthesia
Local anesthetic

Device:
• Holter ECG monitor
3-chanel, CM5 leads

Procedure:
• Open kidney cancer surgery
Lateral position
• General anesthesia

Locations

Country	Name	City	State
Poland	I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 months	Yes
Secondary	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	Yes