Ischemia Clinical Trial
Official title:
Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery
This study compares differences in hemodynamic ve ECG parameters of patients undergoing urological or orthopedic surgery under spinal anesthesia. First group will comprise of patients undergoing surgery in the morning hours; thus with a standard fasting duration (8 hours), and the second group will comprise of patients undergoing surgery afternoon; thus having a prolonged fasting duration (>12 hours).
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Patients over 60 years of age - Patients with an ASA (American Society of Anesthesiologists) physical status score of 1, 2 or 3 - Patients scheduled for elective orthopedic or urological surgery under spinal anesthesia Exclusion Criteria: - Patients requiring emergency surgery - Patients under 60 years of age - Rejecting to participate in the study - Contraindications to spinal anesthesia - Evidence of myocardial ischemia in baseline electrocardiogram prior to surgery - Conditions mimicking electrocardiographic signs of myocardial ischemia (e.g. electrolyte imbalances such as hypokalemia) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Training and Research Hospital | Izmir |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of ischemic changes in 12 lead electrocardiogram | Changes in ST and T waves compared to a baseline preoperative ECG will be monitored and recorded right after spinal block is placed, and at 1st, 2nd, 5th and 15th minutes after spinal injection | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Secondary | Evidence of hypotension confirmed by non-invasive blood pressure measurement | Changes in mean arterial blood pressure will be monitored and a decrease of 10% from baseline mean arterial blood pressure will be recorded as hypotension right after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block spinal block is placed | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Secondary | Evidence of hypertension confirmed by non-invasive blood pressure measurement | Changes in mean arterial blood pressure will be monitored and an increase of 10% from baseline mean arterial blood pressure will be recorded as hypertension right after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Secondary | Evidence of hypoxia confirmed by peripheral oxygen saturation probe | Peripheral oxygen saturation will be continuously monitored and any value less than 90% will be recorded right after spinal block is placed, at first, second, fifth minutes and at 15th minute | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Secondary | Evidence of tachycardia in 12 lead electrocardiogram | A heart rate equal to / higher than 100 will be recorded right after spinal block is placed, at first, second, fifth minutes and again at 15th minute | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Secondary | Evidence of bradycardia in 12-lead electrocardiogram | A heart rate equal to / less than 50 will be recorded right after spinal block is placed, at first, second, fifth minutes and again at 15th minute | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05443061 -
Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children
|
N/A | |
Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
Recruiting |
NCT06006975 -
Early Warning of Delayed Cerebral Ischemia
|
||
Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
Completed |
NCT02758847 -
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
|
N/A | |
Completed |
NCT02557282 -
CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol
|
||
Enrolling by invitation |
NCT02033681 -
Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
|
N/A | |
Completed |
NCT01608035 -
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
|
Phase 0 | |
Active, not recruiting |
NCT01518842 -
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
|
N/A | |
Completed |
NCT01625832 -
Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study)
|
N/A | |
Active, not recruiting |
NCT01281241 -
Study on Mechanical and Electrical Alternans
|
N/A | |
Completed |
NCT00778323 -
Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT00371371 -
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
|
Phase 1/Phase 2 | |
Terminated |
NCT00760708 -
Circulating Adenosine Levels Before and After Intravenous (IV) Persantine
|
||
Not yet recruiting |
NCT06039748 -
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
|
||
Completed |
NCT04879875 -
New Method for Real-time Detection of Tissue Ischemia (ISCALERT)
|
N/A | |
Completed |
NCT00526474 -
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)
|
Phase 3 | |
Completed |
NCT03994822 -
pRESET for Occlusive Stroke Treatment
|
N/A | |
Completed |
NCT02910778 -
The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
|
Phase 4 | |
Completed |
NCT02552498 -
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
|
N/A |