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Effects of Preoperative Fasting on ECG and Vital Parameters

B

Bozyaka Training and Research Hospital

Status

Completed

Conditions

Intraoperative Complications
Ischemia
Fasting

Treatments

Other: Preoperative Fasting for 8 hours
Drug: Spinal Anesthesia with Bupivacaine
Other: Preoperative Fasting for more than 12 hours

Study type

Observational

Funder types

Other

Identifiers

NCT02773199
IzmirBozyaka

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

Cohort 1- Morning Surgery
Description:
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
Treatment:
Drug: Spinal Anesthesia with Bupivacaine
Other: Preoperative Fasting for 8 hours
Cohort 2- Afternoon Surgery
Description:
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
Treatment:
Other: Preoperative Fasting for more than 12 hours
Drug: Spinal Anesthesia with Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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