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Completed

NCT Number: NCT02988219

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

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)

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Key information

About this study

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-fentanyl

Drug

Local anesthetic

Other names: Marcaine, Sensorcaine, Astra Zeneca, Bupivacaine-epinephrine, Fentanyl

Holter ECG monitor

Device

3-chanel, CM5 leads

Open kidney cancer surgery

Procedure

Lateral position

Other names: nephron sparing surgery (NSS), Radical nephrectomy, Extraperitoneal

General Anesthesia

Procedure

Other names: Intubation, Fentanyl, Narcosis

Epidural Anaesthesia

Procedure

Other names: Bupivacaine, Epidural catheter

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Dec 9, 2016
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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