Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evidence of ischemic changes in 12 lead electrocardiogram
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Cohort 1- Morning Surgery
Patients' who are scheduled for surgery under spinal anesthesia with bupivacaine in morning hours (until 12pm) will be included in this cohort. Since all patients are ordered to stop oral ingestion by 12am at the day of the surgery, patients in this cohort will be exposed to a preoperative fasting for 8 hours
Intervention: Preoperative Fasting for 8 hours (Other)
Cohort 1- Morning Surgery
Patients' who are scheduled for surgery under spinal anesthesia with bupivacaine in morning hours (until 12pm) will be included in this cohort. Since all patients are ordered to stop oral ingestion by 12am at the day of the surgery, patients in this cohort will be exposed to a preoperative fasting for 8 hours
Intervention: Spinal Anesthesia with Bupivacaine (Drug)
Cohort 2- Afternoon Surgery
Patients' who are scheduled for surgery under spinal anesthesia with bupivacaine in afternoon hours (after 12pm) will be included in this cohort. Since all patients are ordered to stop oral ingestion by 12am at the day of the surgery, patients in this cohort will be exposed to a preoperative fasting for more than 12 hours
Intervention: Preoperative Fasting for more than 12 hours (Other)
Cohort 2- Afternoon Surgery
Patients' who are scheduled for surgery under spinal anesthesia with bupivacaine in afternoon hours (after 12pm) will be included in this cohort. Since all patients are ordered to stop oral ingestion by 12am at the day of the surgery, patients in this cohort will be exposed to a preoperative fasting for more than 12 hours
Intervention: Spinal Anesthesia with Bupivacaine (Drug)
Outcomes
Primary Outcomes
Evidence of ischemic changes in 12 lead electrocardiogram
Time Frame: 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 Outcomes
- 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)
- 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)
- Evidence of hypoxia confirmed by peripheral oxygen saturation probe(Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block)
- Evidence of tachycardia in 12 lead electrocardiogram(Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block)
- Evidence of bradycardia in 12-lead electrocardiogram(Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block)