Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia

NCT ID: NCT05262933

Last Updated: 2024-05-16

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

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-07-01

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Hypotension After Spinal Anesthesia Post-Dural Puncture Headache

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

coffee (n= 70)

Patients are planned to drink brewed coffee 2 hours before surgery.

coffee

Intervention Type OTHER

It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache

control (n=70)

Patients are planned to drink water 2 hours before surgery.

Water

Intervention Type OTHER

It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache

Interventions

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

coffee

It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache

Intervention Type OTHER

Water

It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache

Intervention Type OTHER

Other Intervention Names

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

It will be given to patients brewed coffee to drink It will be given to patients water to drink

Eligibility Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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

Gamze Talih

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Erciyes University

Kayseri, , 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.

2021/825

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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