- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05262933
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
Completed
Intervention / Treatment
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:
|
|
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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