Arrhythmia, CardiacPhase 4NCT02988219
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
A Phase 4 study testing Bupivacaine-fentanyl, Holter ECG monitor and Open kidney cancer surgery in people with Arrhythmia, Cardiac and Kidney Cancer, run by Medical University of Warsaw at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Cardiac, Kidney Cancer, Surgery
- What is being tested?
- Bupivacaine-fentanyl, Holter ECG monitor and Open kidney cancer surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2010to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open renal cell carcinoma surgery, lateral position
- American Society of Anesthesiologists (ASA) physical grade I-III
- No history of cardiac arrhythmias
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, 02-005
About this study
Official title: Evaluation of 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)
Read the 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.
- Conditions
- Arrhythmia, Cardiac, Kidney Cancer, Surgery, Anesthesia, Local
- Being tested
- Bupivacaine-fentanyl, Holter ECG monitor, Open kidney cancer surgery, General anesthesia, Epidural Anaesthesia
- Keywords
- cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, NSS, radical nephrectomy, extraperitoneal
- Medical subject headings
- Arrhythmias, Cardiac, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanylDrug
Also called Marcaine, Sensorcaine, Astra Zeneca, Bupivacaine-epinephrine
Local anesthetic
Holter ECG monitorDevice
3-chanel, CM5 leads
Open kidney cancer surgeryProcedure or surgery
Also called nephron sparing surgery (NSS), Radical nephrectomy, Extraperitoneal
Lateral position
General anesthesiaProcedure or surgery
Also called Intubation, Fentanyl, Narcosis
Epidural AnaesthesiaProcedure or surgery
Also called Bupivacaine, Epidural catheter
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia (G) | Active comparator | Holter ECG monitor General anesthesia Open kidney cancer surgery Receives: 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 Receives: Drug: Bupivacaine-fentanyl; Device: Holter ECG monitor; Procedure: Open kidney cancer surgery; Procedure: General anesthesia; Procedure: Epidural Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJun 2010
- Primary completionDec 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmia, CardiacStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Dobrońska, Medical University of Warsaw
- Investigators
- Karolina Dobronska, MD, Principal investigator, I Department of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988219
- Sponsor's protocol ID
- U/1/2010
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2016
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33552568
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
- ClinicalTrials.gov ID
- NCT02988219
- Acronym / sponsor ID
- U/1/2010
- Conditions
- Arrhythmia, Cardiac, Kidney Cancer, Surgery, Anesthesia, Local
- Keywords
- cardiac arrhythmia, epidural anesthesia, combined anesthesia, general anesthesia, NSS, radical nephrectomy, extraperitoneal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia (G) | Active comparator | Device: Holter ECG monitor, Procedure: Open kidney cancer surgery, Procedure: General anesthesiaHolter ECG monitor General anesthesia Open kidney cancer surgery |
| Combined general/epidural (G/E) | Experimental | Drug: Bupivacaine-fentanyl, Device: Holter ECG monitor, Procedure: Open kidney cancer surgery, Procedure: General anesthesia, Procedure: Epidural AnaesthesiaHolter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Open renal cell carcinoma surgery, lateral position
- American Society of Anesthesiologists (ASA) physical grade I-III
- No history of cardiac arrhythmias
- Informed consent
Key exclusion criteria (8 listed)
- Pregnancy and breast feeding
- Contraindications for epidural anesthesia
- Laparoscopic or robotic surgery
- Suspected difficult intubation (ex. fibroscopic)
- Chest deformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-fentanylAlso: Marcaine, Sensorcaine, Astra Zeneca, Bupivacaine-epinephrineLocal anesthetic | Drug | Combined general/epidural (G/E) |
| Holter ECG monitor3-chanel, CM5 leads | Device | Combined general/epidural (G/E), General anesthesia (G) |
| Open kidney cancer surgeryAlso: nephron sparing surgery (NSS), Radical nephrectomy, ExtraperitonealLateral position | Procedure or surgery | Combined general/epidural (G/E), General anesthesia (G) |
| General anesthesiaAlso: Intubation, Fentanyl, Narcosis | Procedure or surgery | Combined general/epidural (G/E), General anesthesia (G) |
| Epidural AnaesthesiaAlso: Bupivacaine, Epidural catheter | Procedure or surgery | Combined general/epidural (G/E) |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33552568Dobronska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karolina Dobronska, MD principal investigator
I Department of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-fentanyl, Holter ECG monitor and Open kidney cancer surgery in people with Arrhythmia, Cardiac and Kidney Cancer, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.