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

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Completed
• CT.gov ID: NCT02988219
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 0.6

Study Details

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 After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete.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
• 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: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Karolina Dobrońska, M.D., 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; Epinephrine; Fentanyl; Bupivacaine; Anesthetics

Study Results

Participant Flow

Arm/Group Title	General Anesthesia (G)	Combined General/Epidural (G/E)
Arm/Group Description	General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position	General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
Period Title: Overall Study
STARTED	25	25
COMPLETED	24	22
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	General Anesthesia (G)	Combined General/Epidural (G/E)	Total
Arm/Group Description	General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position	General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position	Total of all reporting groups
Overall Participants	24	22	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 70.8%	20 90.9%	37 80.4%
>=65 years	7 29.2%	2 9.1%	9 19.6%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	61 (8.50)	57 (9.04)	59 (8.58)
Sex: Female, Male (Count of Participants)
Female	11 45.8%	10 45.5%	21 45.7%
Male	13 54.2%	12 54.5%	25 54.3%
Region of Enrollment (participants) [Number]
Poland	24 100%	22 100%	46 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.14 (4.84)	30.04 (7.01)	29.29 (5.99)
ASA (scores on a scale) [Median (Full Range) ]
Median (Full Range) [scores on a scale]	2	2	2
Type of Surgery (Count of Participants)
NSS	12 50%	17 77.3%	29 63%
Nefrectomy	12 50%	5 22.7%	17 37%

Outcome Measures

1. Primary Outcome

Title	Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Description	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
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	General Anesthesia (G)	Combined General/Epidural (G/E)
Arm/Group Description	General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position	General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
Measure Participants	24	22
observed	6 25%	6 27.3%
not observed	18 75%	16 72.7%
observed	2 8.3%	5 22.7%
not observed	22 91.7%	17 77.3%
observed	5 20.8%	4 18.2%
not observed	19 79.2%	18 81.8%
observed	3 12.5%	3 13.6%
not observed	21 87.5%	19 86.4%
observed	14 58.3%	10 45.5%
not observed	10 41.7%	12 54.5%
observed	6 25%	4 18.2%
not observed	18 75%	18 81.8%
observed	16 66.7%	11 50%
not observed	8 33.3%	11 50%
observed	0 0%	0 0%
not observed	24 100%	22 100%
observed	2 8.3%	0 0%
not observed	22 91.7%	22 100%
observed	2 8.3%	2 9.1%
not observed	22 91.7%	20 90.9%
observed	2 8.3%	2 9.1%
not observed	22 91.7%	20 90.9%
observed	1 4.2%	0 0%
not observed	23 95.8%	22 100%
observed	1 4.2%	1 4.5%
not observed	23 95.8%	21 95.5%
observed	1 4.2%	2 9.1%
not observed	23 95.8%	20 90.9%
observed	1 4.2%	2 9.1%
not observed	23 95.8%	20 90.9%
observed	1 4.2%	1 4.5%
not observed	23 95.8%	21 95.5%
observed	3 12.5%	1 4.5%
not observed	21 87.5%	21 95.5%
observed	3 12.5%	2 9.1%
not observed	21 87.5%	20 90.9%
observed	3 12.5%	3 13.6%
not observed	21 87.5%	19 86.4%
observed	0 0%	0 0%
not observed	24 100%	22 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	Bradycardia during surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3861
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	No bradycardia observed in the perioperative period
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2591
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
Description	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
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

arrhythmias analysed: bradycardia, pause > 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)

Arm/Group Title	General Anesthesia (G)	Combined General/Epidural (G/E)
Arm/Group Description	General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position	General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
Measure Participants	24	22
observed	3 12.5%	4 18.2%
not observed	21 87.5%	18 81.8%
observed	16 66.7%	12 54.5%
not observed	8 33.3%	10 45.5%
observed	8 33.3%	6 27.3%
not observed	16 66.7%	16 72.7%
observed	0 0%	0 0%
not observed	24 100%	22 100%
observed	0 0%	2 9.1%
not observed	24 100%	20 90.9%
observed	1 4.2%	6 27.3%
not observed	23 95.8%	16 72.7%
observed	1 4.2%	8 36.4%
not observed	23 95.8%	14 63.6%
observed	0 0%	0 0%
not observed	24 100%	22 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	Arrhythmia before surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.597
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	arrhythmia during surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	arrhythmia after surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6544
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	long QTc > 0.45s after surgery
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.077
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	General Anesthesia (G), Combined General/Epidural (G/E)
	Comments	long QTc > 0.24 s in the perioperative time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0174
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	General Anesthesia (G)		Combined General/Epidural (G/E)
Arm/Group Description	General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position		General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
All Cause Mortality
	General Anesthesia (G)		Combined General/Epidural (G/E)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	General Anesthesia (G)		Combined General/Epidural (G/E)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	General Anesthesia (G)		Combined General/Epidural (G/E)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.