Phase 4
N=50
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Arrhythmia, Cardiac · Kidney Cancer · Surgery · Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT02988219 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period — 6; 6; 18; 16 Participants — p=0.3861
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine-fentanyl (Drug); Holter ECG monitor (Device); Open kidney cancer surgery (Procedure); General anesthesia (Procedure); Epidural Anaesthesia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Warsaw
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period |
6; 6; 18; 16; 2; 5 | 0.3861 |
| SECONDARY The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed |
3; 4; 21; 18; 16; 12 | 0.597 |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02988219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.