Effect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean Section

NCT06060015 | Unknown Phase 4

• 1 other identifier: 168/23
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section

Conditions

Anesthesia; Obstetric Anesthesia Problems

Keywords

Anesthesia; Obesity; Cesarean; Subarachnoid; Bupivacaine; pregnancy

Outcome Measures

Primary Outcomes (3)

• Assess the mean blood pressure

  Number of pregnant patients with obesity who present a decrease in mean arterial pressure after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery

  3 hour

• Determine the effects on the heart rate

  Number of pregnant patients with obesity who present changes in heart rate such as bradycardia (heart rate less than 60 beats minute) or tachycardia (heart rate greater than 120 beats minute) after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery

  3 hour

• Determine the effects on the O2 saturation

  Number of pregnant patients with obesity who present changes in O2 saturation after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery

  3 hour

Secondary Outcomes (4)

• Describe the adverse effects (nausea or vomiting)

  3 hour

• Identify the level of sensory blockade

  15 minutes

• Describe the adverse effects on the fetus

  1 hour

• Document the Apgar score

  5 minutes

Study Arms (2)

5mg bupivacaine

EXPERIMENTAL

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

Drug: 5mg bupivacaine

10mg bupivacaine

EXPERIMENTAL

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

Drug: 10mg bupivacaine

Interventions

5mg bupivacaine DRUG

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

Also known as: hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1ml

5mg bupivacaine

10mg bupivacaine DRUG

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

Also known as: hyperbaric bupivacaine 2ml, bupivacaine/Dextrose 2ml

10mg bupivacaine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Single fetus and pregnancy whit BMI≥ 30 kg/m2
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Related Publications (39)

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Related Links

• World Health Organization. Obesity and Overweight Descriptive note No 311.

MeSH Terms

Conditions

Obesity

Interventions

Bupivacaine; Glucose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• María de los Angeles Campechano Ascencio, MSc

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

• Miriam Mendez del Villar, PhD

  Universidad de Guadalajara Centro Universitario de Tonalá

  STUDY DIRECTOR

• Leonel Garcia Benavides, PhD

  Universidad de Guadalajara Centro Universitario de Tonalá

  STUDY CHAIR

• Jorge Bravo Rubio, MSc

  Hospital Civil de Guadalajara

  STUDY CHAIR

• Edy David Rubio Arellano, MSc

  Universidad de Guadalajara Centro Universitario Ciencias de la Salud

  STUDY CHAIR

Central Study Contacts

María de los Angeles Campechano Ascencio, MSc

CONTACT

+5213310233983; angelescampechano@hotmail.com

Miriam Mendez del Villar, PhD

CONTACT

+5213310640220; miriamendez@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: You do not know the dose of bupivacaine you receive
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anestesiologist

Model Details: Clinical trial open controlled parallel randomized simple

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 29, 2023
• Study Start: August 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)