Fasting, Intraoperative Complications, Ischemia
Conditions
Brief summary
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).
Detailed description
Patients who are scheduled for surgery in surgical wards are routinely fasted after 12am on the day of the surgery regardless of the planned hour of the surgery. This results in a near standard fasting for patients with a planned surgery time in morning hours of the day. However, patients with a planned surgery time in the afternoon hours of the day are fasted more than 12 hours. This situation may not look very important for a healthy young adult but considering that the patient population in a hospital is mostly consisted of sick and elderly people, fasting and associated dehydration may have serious deleterious effects. Our objective is to observe and define these potential deleterious effects with a special focus on cardiovascular system of the patients.
Interventions
OTHERPreoperative Fasting for 8 hours
Patients will be exposed to preoperative fasting
OTHERPreoperative Fasting for more than 12 hours
Patients will be exposed to preoperative fasting
Spinal Anesthesia with heavy bupivacaine 0.5% is provided.
Sponsors
Bozyaka Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of ischemic changes in 12 lead electrocardiogram | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of hypotension confirmed by non-invasive blood pressure measurement | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
| Evidence of hypertension confirmed by non-invasive blood pressure measurement | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
| Evidence of hypoxia confirmed by peripheral oxygen saturation probe | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
| Evidence of tachycardia in 12 lead electrocardiogram | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
| Evidence of bradycardia in 12-lead electrocardiogram | Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed