Clinical trial NCT02773199: Effects of Preoperative Fasting on ECG and Vital Parameters
Official title: Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Intraoperative Complications
Ischemia
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 60 who scheduled for urological or orthopedic surgery under spinal anesthesia

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evidence of ischemic changes in 12 lead electrocardiogram
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
Secondary outcomes:
measure: Evidence of hypotension confirmed by non-invasive blood pressure measurement
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
measure: Evidence of hypertension confirmed by non-invasive blood pressure measurement
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
measure: Evidence of hypoxia confirmed by peripheral oxygen saturation probe
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
measure: Evidence of tachycardia in 12 lead electrocardiogram
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
measure: Evidence of bradycardia in 12-lead electrocardiogram
timeFrame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Oguzhan Yeniay, MD
role: PRINCIPAL_INVESTIGATOR
References: