Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia

Post-Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05262933
• Other study ID #: 2021/825
• Status: Not yet recruiting
• Start date: March 15, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2022
• Source: TC Erciyes University
• Contact: Gamze Talih
• Phone: +905447604780
• Email: gamzetalih[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Hypotension
• Hypotension After Spinal Anesthesia
• Post-Dural Puncture Headache

Intervention

Other:
• coffee
It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache
• Water
It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypotension	effects of orally coffee intake on spinal anesthesia induced hypotension	intraoperative time period
Secondary	Post-dural puncture headache	Effects of orally coffee intake on postdural puncture headache	post operative 3 days
Secondary	intestinal motility, first flatus	Effects of orally coffee intake on postoperative intestinal motility	post operative 3 days