Subarachnoid Bupivacaine in Obese Patients Undergoing Cesarean Delivery

NCT04205344 | Completed Phase 4

• 1 other identifier: 005/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of subarachnoid hyperbaric bupivacaine on mean arterial blood pressure (MAP) of pregnant patients with obesity undergoing cesarean section half of the patients will receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg while the other half will receive a dose of 10 mg

Conditions

Anesthesia, Obstetrical

Keywords

Bupivacaine; Obesity; Pregnant; Subarachnoid; Cesarean; Subdural

Outcome Measures

Primary Outcomes (3)

• Assess the mean blood pressure

  Number of participants with a decrease in mean arterial blood pressure after administration of subarachnoid hyperbaric bupivacaine at a dose of 5 mg and 10 mg to preserve the mean blood pressure in pregnant patients with obesity undergoing caesarean section

  2 hours

• Determine the effects on the heart rate

  Number of participants presenting 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 in the pregnant patients with obesity, after subarachnoid block

  2 hour

• Determine the effects on the respiratory rate

  Number of participants presenting changes in respiratory rate such as bradypnea (respiratory rate less than 12 minute breaths) after administration of subarachnoid hyperbaric bupivacaine in the pregnant patient with obesity, after subarachnoid block

  2 hour

Secondary Outcomes (6)

• Describe the adverse effects

  2 hours

• Identify the level of sensory blockade

  15 minutes

• Identify the intensity of motor blockade

  15 minutes

• Measure the duration of the block

  2 hour

• Describe the adverse effects on the fetus

  1 hour

Study Arms (2)

Bupivacaine 5 mg

EXPERIMENTAL

Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg

Drug: Bupivacaine 5 mg

Bupivacaine 10 mg

EXPERIMENTAL

Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg

Drug: Bupivacaine 10 mg

Interventions

Bupivacaine 5 mg DRUG

Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg

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

Bupivacaine 5 mg

Bupivacaine 10 mg DRUG

Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg

Also known as: hyperbaric bupivacaine 2 ml, bupivacaine/Dextrose 1 ml

Bupivacaine 10 mg

Eligibility Criteria

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

You may qualify if:

• Patients with single fetus pregnancy ≥37 weeks gestation
• 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:

• Patients with a known allergy to local anesthetics
• Patients with psychiatric treatment (antidepressants, anxiolytics, antipsychotics)
• Patients with addiction to any type of drug
• Patients with a history of liver disease
• Patients with a history of renal pathology
• Patients with a history of pulmonary pathology
• Patients with a history of cardiac pathology
• Patients with a history of high blood pressure
• Patient with a history of type I, II and gestational diabetes
• Non-calming fetal state
• Patients who refuse the anesthetic technique of neuraxial block

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (31)

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• American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.

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• Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.

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Related Links

• Legislative power
• 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

• MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, MSc

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

• MIRIAM MENDEZ DEL VILLAR, MSc PhD

  CENTRO UNIVERSITARIO DE TONALA

  STUDY DIRECTOR

• LEONEL GARCIA BENAVIDES

  Hospital Civil de Guadalajara

  STUDY CHAIR

• JORGE BRAVO RUBIO

  Hospital Civil de Guadalajara

  STUDY CHAIR

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: Anesthesiologist

Model Details: Clinical trial open controlled parallel randomized simple

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 19, 2019
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: May 30, 2018
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)