Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia

May 14, 2024 updated by: Gamze Talih, TC Erciyes University

Effect of Preoperative Coffee Consumption on Intraoperative and Post Operative Outcomes in Cesarean Section With Spinal Anesthesia

The prospective study is planned in a university hospital. Spinal anesthesia is widely used for cesarean section currently for its safety, low cost, reliability, easiness to administer, immediate effect, and well-operating conditions. However spinal anesthesia has some complications as hypotension, bradycardia and Post Dural Puncture Headache (PDPH). A practical strategy for avoiding hypotension during initiation of spinal anesthesia for cesarean delivery includes intravenous crystalloid, in conjunction with administration of vasopressors. PDPH is one of the most frequent complications of spinal anesthesia. Conservative therapies such as bed rest, hydration, and caffeine are commonly used as management. For this study, coffee group of patients will be given unsweetened brewed coffee 150 ml until 2-4 hours before surgery. Patients who accept to drink brewed coffee ( coffee group) and water( control group) will be included in the study. The patient's heart rate, blood pressure, oxygen saturation will be monitored and recorded during operation. Intraoperative will be recorded to amount of vasopressor and intraveous crystalloid. Whether the patient develops PDPH in the postoperative period will be followed for 3 days. In addition abdominal auscultation for bowel sounds hourly and the time of first bowel movements will be recorded. According to the patient's statement, the time of first flatulence and defecation will be followed and recorded.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Kayseri, Turkey
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

parturient women aged 18-45

Description

Inclusion Criteria:

  • patients who accept to participate in the study
  • patient who limit the consumption of caffeinated beverages such as coffee and tea during pregnancy
  • Patients with known caffeine or coffee allergy

Exclusion Criteria:

  • patients who refuse to participate in the study
  • Patients with known cardiovascular disease
  • Patients with known cerebrovascular disease
  • patients with known neurological, neurodegenerative or psychiatric disease
  • patients with known liver failure
  • patient followed up with eclampsia and preaclampsi
  • higher number of needle passes in spinal anesthesia
  • patients treated with an antiemetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
coffee (n= 70)
Patients are planned to drink brewed coffee 2 hours before surgery.
Other: coffee
It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache
Other Names:
  • It will be given to patients brewed coffee to drink
control (n=70)
Patients are planned to drink water 2 hours before surgery.
Other: Water
It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache
Other Names:
  • It will be given to patients water to drink

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
hypotension
Time Frame: intraoperative time period
effects of orally coffee intake on spinal anesthesia induced hypotension
intraoperative time period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-dural puncture headache
Time Frame: post operative 3 days
Effects of orally coffee intake on postdural puncture headache
post operative 3 days
intestinal motility, first flatus
Time Frame: post operative 3 days
Effects of orally coffee intake on postoperative intestinal motility
post operative 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/825

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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