Effects of Preoperative Fasting on ECG and Vital Parameters

NCT02773199 | Completed

• 1 other identifier: IzmirBozyaka
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Fasting; Intraoperative Complications; Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evidence of hypotension confirmed by non-invasive blood pressure measurement

  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

  Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block

• Evidence of hypoxia confirmed by peripheral oxygen saturation probe

  Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block

• Evidence of tachycardia in 12 lead electrocardiogram

  Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block

• Evidence of bradycardia in 12-lead electrocardiogram

  Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block

Study Arms (2)

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; Drug: Spinal Anesthesia with Bupivacaine

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; Drug: Spinal Anesthesia with Bupivacaine

Interventions

Preoperative Fasting for 8 hours OTHER

Patients will be exposed to preoperative fasting

Also known as: Shorter Fasting

Cohort 1- Morning Surgery

Preoperative Fasting for more than 12 hours OTHER

Patients will be exposed to preoperative fasting

Also known as: Longer Fasting

Cohort 2- Afternoon Surgery

Spinal Anesthesia with Bupivacaine DRUG

Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

Also known as: Spinal Block

Cohort 1- Morning Surgery; Cohort 2- Afternoon Surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasting; Intraoperative Complications; Ischemia

Interventions

Anesthesia, Spinal; Bupivacaine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Oguzhan Yeniay, MD

  Izmir Bozyaka Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)