Suspended

Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

5mg bupivacaine

+ 10mg bupivacaine

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 45 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 4
Interventional
Study Start: August 2023
See protocol details

Summary

Principal SponsorHospital Civil de Guadalajara
Study ContactMaría de los Angeles Campechano Ascencio, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial is investigating how a specific anesthetic called subarachnoid hyperbaric bupivacaine affects blood pressure in obese pregnant women who are undergoing a C-section. The trial focuses on women who are at least 37 weeks pregnant, have a BMI of 30 or above, and have babies that are doing well. This research is important because keeping blood pressure stable during surgery is crucial for the safety of both the mother and the baby. Understanding the effects of this anesthetic could improve the care provided during cesarean sections for obese patients. In the study, participants receive anesthesia through a mixed technique that involves both epidural and subarachnoid blocks. The procedure begins with a thorough pre-anesthetic evaluation and monitoring of vital signs. Patients are randomly assigned to receive different doses of the anesthetic, either 5 mg or 10 mg, to observe its effect on mean arterial pressure (MAP). The researchers monitor vital signs frequently during surgery and assess sensory and motor blockades. They also record nausea and vomiting incidents, and evaluate the newborn's condition using the Apgar score. Data collected will help determine if the anesthetic dose affects blood pressure and overall surgical outcomes, providing insights into safer anesthetic practices for obese pregnant patients.

Official TitleEffect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section
Principal SponsorHospital Civil de Guadalajara
Study ContactMaría de los Angeles Campechano Ascencio, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

7 exclusion criteria prevent from participating
Allergy to local anesthetics

Psychiatric treatment (antidepressants, anxiolytics, antipsychotics)

Addiction to any type of drug

Liver, renal, pulmonary or cardiac disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg

Group II

Experimental
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Civil de Guadalajara

Guadalajara, MexicoOpen Hospital Civil de Guadalajara in Google Maps
SuspendedOne Study Center