Effects of Preoperative Fasting on ECG and Vital Parameters

NCT ID: NCT02773199

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Fasting Intraoperative Complications Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Preoperative Fasting for 8 hours

Intervention Type OTHER

Patients will be exposed to preoperative fasting

Spinal Anesthesia with Bupivacaine

Intervention Type DRUG

Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

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

Preoperative Fasting for more than 12 hours

Intervention Type OTHER

Patients will be exposed to preoperative fasting

Spinal Anesthesia with Bupivacaine

Intervention Type DRUG

Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preoperative Fasting for 8 hours

Patients will be exposed to preoperative fasting

Intervention Type OTHER

Preoperative Fasting for more than 12 hours

Patients will be exposed to preoperative fasting

Intervention Type OTHER

Spinal Anesthesia with Bupivacaine

Spinal Anesthesia with heavy bupivacaine 0.5% is provided.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Shorter Fasting Longer Fasting Spinal Block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oguzhan Yeniay, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IzmirBozyaka

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.