Using hyperbaric bupivacaine for anesthesia in obese pregnant women having a cesarean section
Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section
PHASE4 · Hospital Civil de Guadalajara · NCT06060015
This study is testing whether two different doses of a specific anesthesia can help keep blood pressure stable in obese pregnant women having a cesarean section.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hospital Civil de Guadalajara (other) |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT06060015 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two different doses of hyperbaric subarachnoid bupivacaine (5 mg vs 10 mg) on mean arterial pressure in obese pregnant patients undergoing cesarean sections. Eligible participants are women over 18 years of age, with a BMI of 30 kg/m2 or higher, and at least 37 weeks of gestation. The study involves a mixed technique neuraxial block for anesthesia, with careful monitoring of vital signs and fetal well-being throughout the procedure. Participants will be randomly assigned to one of the two dosage groups after providing informed consent.
Who should consider this trial
Good fit: Ideal candidates are obese pregnant women with a BMI of 30 kg/m2 or higher, at least 37 weeks of gestation, and scheduled for a cesarean section.
Not a fit: Patients with allergies to local anesthetics, significant comorbidities, or those with a non-calming fetal state may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve anesthesia management and outcomes for obese pregnant patients undergoing cesarean sections.
How similar studies have performed: While there have been studies on anesthesia in obese patients, the specific use of hyperbaric bupivacaine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnancy ≥37 weeks gestation with single fetus * Body mass index (BMI) ≥ 30 kg/m2 * Indication of termination of pregnancy via abdominal caesarean section * Indication of subarachnoid neuraxial block under mixed technique * Signing of consent under information Exclusion Criteria: * Allergy to local anesthetics * Psychiatric treatment (antidepressants, anxiolytics, antipsychotics) * Addiction to any type of drug * Liver, renal, pulmonary or cardiac disease * High blood pressure * Type I, II and gestational diabetes * Diagnostic of non-calming fetal state
Where this trial is running
Guadalajara, Jalisco
- Hospital Civil de Guadalajara — Guadalajara, Jalisco, Mexico (RECRUITING)
Study contacts
- Principal investigator: María de los Angeles Campechano Ascencio, MSc — Hospital Civil de Guadalajara
- Study coordinator: María de los Angeles Campechano Ascencio, MSc
- Email: angelescampechano@hotmail.com
- Phone: +5213310233983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Obstetric Anesthesia Problems, Obesity, Cesarean, Subarachnoid, Bupivacaine, pregnancy