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Effects of Preoperative Fasting on ECG and Vital Parameters

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ClinicalTrials.gov Identifier: NCT02773199
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bozyaka Training and Research Hospital

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).

Condition or disease Intervention/treatment
Fasting Intraoperative Complications Ischemia Other: Preoperative Fasting for 8 hours Other: Preoperative Fasting for more than 12 hours Drug: Spinal Anesthesia with Bupivacaine

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery
Study Start Date : May 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

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 Name: Shorter Fasting

Drug: Spinal Anesthesia with Bupivacaine
Spinal Anesthesia with heavy bupivacaine 0.5% is provided.
Other Name: 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
Other: Preoperative Fasting for more than 12 hours
Patients will be exposed to preoperative fasting
Other Name: Longer Fasting

Drug: Spinal Anesthesia with Bupivacaine
Spinal Anesthesia with heavy bupivacaine 0.5% is provided.
Other Name: Spinal Block




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over the age of 60 who scheduled for urological or orthopedic surgery under spinal anesthesia
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773199


Locations
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Turkey
Izmir Bozyaka Training and Research Hospital
Izmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
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Principal Investigator: Oguzhan Yeniay, MD Izmir Bozyaka Training and Research Hospital
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Responsible Party: Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02773199    
Other Study ID Numbers: IzmirBozyaka
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ischemia
Intraoperative Complications
Pathologic Processes
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents