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Completed

NCT Number: NCT02773199

Effects of Preoperative Fasting on ECG and Vital Parameters

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).

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Key information

Conditions

Fasting Behavior Feeding Behavior Intraoperative Complications Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Preoperative Fasting for 8 hours

Other

Patients will be exposed to preoperative fasting

Other names: Shorter Fasting

Preoperative Fasting for more than 12 hours

Other

Patients will be exposed to preoperative fasting

Other names: Longer Fasting

Spinal Anesthesia with Bupivacaine

Drug

Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

Other names: Spinal Block

Primary outcomes

  1. 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

  1. Evidence of hypotension confirmed by non-invasive blood pressure measurement

    Time frame: 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

  2. Evidence of hypertension confirmed by non-invasive blood pressure measurement

    Time frame: 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

  3. Evidence of hypoxia confirmed by peripheral oxygen saturation probe

    Time frame: 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

  4. Evidence of tachycardia in 12 lead electrocardiogram

    Time frame: 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

  5. Evidence of bradycardia in 12-lead electrocardiogram

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 16, 2016
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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