Effects of Preoperative Fasting on ECG and Vital Parameters

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).

Study Overview

• Status: Completed
• Conditions: Ischemia; Intraoperative Complications; Fasting
• Intervention / Treatment: Other: Preoperative Fasting for 8 hours; Drug: Spinal Anesthesia with Bupivacaine; Other: Preoperative Fasting for more than 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35170
    • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over the age of 60 who scheduled for urological or orthopedic surgery under spinal anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Preoperative Fasting for 8 hours; Patients will be exposed to preoperative fasting; Other Names: Shorter Fasting; Drug: Spinal Anesthesia with Bupivacaine; Spinal Anesthesia with heavy bupivacaine 0.5% is provided.; Other Names: Spinal Block
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	Drug: Spinal Anesthesia with Bupivacaine; Spinal Anesthesia with heavy bupivacaine 0.5% is provided.; Other Names: Spinal Block; Other: Preoperative Fasting for more than 12 hours; Patients will be exposed to preoperative fasting; Other Names: Longer Fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Principal Investigator: Oguzhan Yeniay, MD, Izmir Bozyaka Training and Research Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 16, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Intraoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IzmirBozyaka

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO