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

• ClinicalTrials.gov Identifier: NCT02988219
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Results First Posted: April 25, 2017
• Last Update Posted: May 30, 2017
• Sponsor: Medical University of Warsaw
• Information provided by (Responsible Party): Karolina Dobrońska, Medical University of Warsaw

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Arrhythmia, Cardiac; Kidney Cancer; Surgery; Anesthesia, Local	Drug: Bupivacaine-fentanyl; Device: Holter ECG monitor; Procedure: Open kidney cancer surgery; Procedure: General anesthesia; Procedure: Epidural Anaesthesia	Phase 4

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
• Study Start Date: June 2010
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: General anesthesia (G); Holter ECG monitor General anesthesia Open kidney cancer surgery	Device: Holter ECG monitor; 3-chanel, CM5 leads; Procedure: Open kidney cancer surgery; Lateral position; Other Names: nephron sparing surgery (NSS); Radical nephrectomy; Extraperitoneal; Procedure: General anesthesia; Other Names: Intubation; Fentanyl; Narcosis
Experimental: Combined general/epidural (G/E); Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery	Drug: Bupivacaine-fentanyl; Local anesthetic; Other Names: Marcaine; Sensorcaine; Astra Zeneca; Bupivacaine-epinephrine; Fentanyl; Device: Holter ECG monitor; 3-chanel, CM5 leads; Procedure: Open kidney cancer surgery; Lateral position; Other Names: nephron sparing surgery (NSS); Radical nephrectomy; Extraperitoneal; Procedure: General anesthesia; Other Names: Intubation; Fentanyl; Narcosis; Procedure: Epidural Anaesthesia; Other Names: Bupivacaine; Epidural catheter

Outcome Measures

Primary Outcome Measures :

1. Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period [ Time Frame: 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 :

1. The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Poland

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Warsaw, Poland, 02-005

Sponsors and Collaborators

Medical University of Warsaw

Investigators

• Principal Investigator: Karolina Dobronska, MD; I Department of Anaesthesiology and Intensive Care

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Karolina Dobrońska, M.D., Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT02988219
• Other Study ID Numbers: U/1/2010
• First Posted: December 9, 2016
• Results First Posted: April 25, 2017
• Last Update Posted: May 30, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Karolina Dobrońska, Medical University of Warsaw:

cardiac arrhythmia; epidural anesthesia; combined anesthesia; general anesthesia; NSS; radical nephrectomy; extraperitoneal

Additional relevant MeSH terms:

Kidney Neoplasms; Carcinoma, Renal Cell; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Epinephrine; Fentanyl; Bupivacaine; Anesthetics; Anesthetics, Local; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia; Anesthetics, Intravenous