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

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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

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
Intervention / Treatment
coffee (n= 70)
Patients are planned to drink brewed coffee 2 hours before surgery.
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.
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

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

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

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.

Clinical Trials on Post-Dural Puncture Headache

Clinical Trials on coffee

Subscribe