Hypotension After Spinal AnesthesiaNCT05262933
Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia
An observational study of Hypotension After Spinal Anesthesia and Post-Dural Puncture Headache, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension After Spinal Anesthesia, Post-Dural Puncture Headache
- What is being tested?
- coffee and Water
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: parturient women aged 18-45
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- coffee, Water
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeOther
Also called It will be given to patients brewed coffee to drink
It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache
WaterOther
Also called It will be given to patients water to drink
It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache
| Study group | Role | What they receive |
|---|---|---|
| coffee (n= 70) | Patients are planned to drink brewed coffee 2 hours before surgery. Receives: Other: coffee | |
| control (n=70) | Patients are planned to drink water 2 hours before surgery. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension
effects of orally coffee intake on spinal anesthesia induced hypotension
Measured: intraoperative time period
Secondary outcomes (2)
Post-dural puncture headache
Effects of orally coffee intake on postdural puncture headache
Measured: post operative 3 days
intestinal motility, first flatus
Effects of orally coffee intake on postoperative intestinal motility
Measured: post operative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Talih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262933
- Sponsor's protocol ID
- 2021/825
- Status last verified
- May 2024
- First submitted
- 21 Feb 2022
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Coffee Consumption on Intraoperative and Post Operative Outcomes in Cesarean Section With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05262933
- Acronym / sponsor ID
- 2021/825
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coffee (n= 70) | – | Other: coffeePatients are planned to drink brewed coffee 2 hours before surgery. |
| control (n=70) | – | Other: WaterPatients are planned to drink water 2 hours before surgery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- parturient women aged 18-45
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coffeeAlso: It will be given to patients brewed coffee to drinkIt will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache | Other | coffee (n= 70) |
| WaterAlso: It will be given to patients water to drinkIt will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache | Other | control (n=70) |
Primary outcome
hypotension
Time frame: intraoperative time period
effects of orally coffee intake on spinal anesthesia induced hypotension
2 secondary outcomes
Post-dural puncture headache
Time frame: post operative 3 days
intestinal motility, first flatus
Time frame: post operative 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension After Spinal Anesthesia and Post-Dural Puncture Headache, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotension (time frame: intraoperative time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.