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

NCT02988219 | Completed Phase 4 Results

• 1 other identifier: U/1/2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  60 months

Secondary Outcomes (1)

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

  60 months

Study Arms (2)

General anesthesia (G)

ACTIVE COMPARATOR

Holter ECG monitor General anesthesia Open kidney cancer surgery

Device: Holter ECG monitor; Procedure: Open kidney cancer surgery; Procedure: General anesthesia

Combined general/epidural (G/E)

EXPERIMENTAL

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

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

Interventions

Bupivacaine-fentanyl DRUG

Local anesthetic

Also known as: Marcaine, Sensorcaine, Astra Zeneca, Bupivacaine-epinephrine, Fentanyl

Combined general/epidural (G/E)

Holter ECG monitor DEVICE

3-chanel, CM5 leads

Combined general/epidural (G/E); General anesthesia (G)

Open kidney cancer surgery PROCEDURE

Lateral position

Also known as: nephron sparing surgery (NSS), Radical nephrectomy, Extraperitoneal

Combined general/epidural (G/E); General anesthesia (G)

General anesthesia PROCEDURE

Also known as: Intubation, Fentanyl, Narcosis

Combined general/epidural (G/E); General anesthesia (G)

Epidural Anaesthesia PROCEDURE

Also known as: Bupivacaine, Epidural catheter

Combined general/epidural (G/E)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open renal cell carcinoma surgery, lateral position
• American Society of Anesthesiologists (ASA) physical grade I-III
• No history of cardiac arrhythmias
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, 02-005, Poland

Location

Related Publications (1)

• 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.

  PMID: 33552568 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Kidney Neoplasms

Interventions

Bupivacaine; Fentanyl; Anesthesia, General; Intubation; Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia; Therapeutics; Investigative Techniques; Anesthesia, Conduction

Results Point of Contact

• Title: Dr. Karolina Dobronska
• Organization: Warsaw Medical University

karolinapladzyk@gmail.com

48 22 502 17 21

Study Officials

• Karolina Dobronska, MD

  I Department of Anaesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)