FastingNCT02773199
Effects of Preoperative Fasting on ECG and Vital Parameters
An observational study of Fasting and Intraoperative Complications, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fasting, Intraoperative Complications, Ischemia
- What is being tested?
- Preoperative Fasting for 8 hours, Preoperative Fasting for more than 12 hours and Spinal Anesthesia with Bupivacaine
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 60 who scheduled for urological or orthopedic surgery under spinal anesthesia
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir, İzmir, 35170
About this study
Official title: 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).
Read the 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.
- Conditions
- Fasting, Intraoperative Complications, Ischemia
- Being tested
- Preoperative Fasting for 8 hours, Preoperative Fasting for more than 12 hours, Spinal Anesthesia with Bupivacaine
- Medical subject headings
- Fasting, Intraoperative Complications, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Fasting for 8 hoursOther
Also called Shorter Fasting
Patients will be exposed to preoperative fasting
Preoperative Fasting for more than 12 hoursOther
Also called Longer Fasting
Patients will be exposed to preoperative fasting
Spinal Anesthesia with BupivacaineDrug
Also called Spinal Block
Spinal Anesthesia with heavy bupivacaine 0.5% is provided.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Preoperative Fasting for more than 12 hours; Drug: Spinal Anesthesia with Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oguzhan Yeniay, MD, Principal investigator, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773199
- Sponsor's protocol ID
- IzmirBozyaka
- Status last verified
- Oct 2016
- First submitted
- 11 May 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Fasting on ECG and Vital Parameters in Patients Undergoing Orthopedic and Urologic Surgery
- ClinicalTrials.gov ID
- NCT02773199
- Acronym / sponsor ID
- IzmirBozyaka
- Conditions
- Fasting, Intraoperative Complications, Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- Morning Surgery | – | Other: Preoperative Fasting for 8 hours, Drug: Spinal Anesthesia with BupivacainePatients' 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 |
| Cohort 2- Afternoon Surgery | – | Other: Preoperative Fasting for more than 12 hours, Drug: Spinal Anesthesia with BupivacainePatients' 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 60 who scheduled for urological or orthopedic surgery under spinal anesthesia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Fasting for 8 hoursAlso: Shorter FastingPatients will be exposed to preoperative fasting | Other | Cohort 1- Morning Surgery |
| Preoperative Fasting for more than 12 hoursAlso: Longer FastingPatients will be exposed to preoperative fasting | Other | Cohort 2- Afternoon Surgery |
| Spinal Anesthesia with BupivacaineAlso: Spinal BlockSpinal Anesthesia with heavy bupivacaine 0.5% is provided. | Drug | Cohort 1- Morning Surgery, Cohort 2- Afternoon Surgery |
Primary outcome
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
5 secondary outcomes
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
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
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
Evidence of tachycardia in 12 lead electrocardiogram
Time frame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
Evidence of bradycardia in 12-lead electrocardiogram
Time frame: Immediately after, 1, 2, 5 and 15 minutes after injection of bupivacaine for spinal block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oguzhan Yeniay, MD principal investigator
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Intraoperative Complications, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.