Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia

NCT05262933 | Completed

• 1 other identifier: 2021/825
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension After Spinal Anesthesia; Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• hypotension

  effects of orally coffee intake on spinal anesthesia induced hypotension

  intraoperative time period

Secondary Outcomes (2)

• Post-dural puncture headache

  post operative 3 days

• intestinal motility, first flatus

  post operative 3 days

Study Arms (2)

coffee (n= 70)

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

Other: coffee

control (n=70)

Patients are planned to drink water 2 hours before surgery.

Other: Water

Interventions

coffee OTHER

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

Also known as: It will be given to patients brewed coffee to drink

coffee (n= 70)

Water OTHER

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

Also known as: It will be given to patients water to drink

control (n=70)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

parturient women aged 18-45

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Coffee; Water

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: March 15, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)