Effects of Preoperative Fasting on ECG and Vital Parameters

Ischemia Clinical Trial

Official title:

Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773199
• Other study ID #: IzmirBozyaka
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: October 17, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fasting
• Intraoperative Complications
• Ischemia

Intervention

Other:
• Preoperative Fasting for 8 hours
Patients will be exposed to preoperative fasting
• Preoperative Fasting for more than 12 hours
Patients will be exposed to preoperative fasting

Drug:
• Spinal Anesthesia with Bupivacaine
Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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