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

September 22, 2023 updated by: María de los Angeles Campechano Ascencio, Hospital Civil de Guadalajara

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients over 18 years of age, with a pregnancy of ≥37 weeks of gestation and adequate fetal well-being, with obesity with a BMI ≥30 kg/m2 presented for cesarean surgery will be included in the study. The objectives of the study protocol, benefits, and benefits will be explained to them. and risks and by election by sealed envelope will be assigned to one of the two study groups, they will be given to sign the consent letter under information. They underwent pre-anesthetic evaluation, baseline vital signs: non-invasive blood pressure, mean arterial pressure (MAP), O2 saturation and heart rate, fetal heart rate will be recorded from the fetal monitor. A preload of Hartmann's solution fluids at 10ml/kg of pre-pregnancy weight and premedication with omeprazole 40mg and metoclopramide 10mg will be administered. Once inside the operating room, baseline vital signs will be recorded and the placement of anesthesia with mixed technique neuraxial block (epidural catheter placement + subarachnoid block) will begin in a sitting position, the anatomical reference of the intervertebral space L2-L3, L3- will be located. L4. The aseptic and antiseptic technique with povidone-iodine and alcohol will be performed on the skin, sterile fields will be placed, the skin and subcutaneous tissue will be infiltrated with 5 ml of 2% lidocaine, a Tuohy No. 17 needle is inserted with the "hanging Drop" technique, to locate the epidural space, it was corroborated with the "loss of resistance" technique. Through the "Tuohy needle", the "spinal needle" No. 27 spinal needle is inserted until cerebrospinal fluid (CSF) is obtained. The blocking dose of hyperbaric bupivacaine of 10 mg (2 ml) or mg (1 ml) will be administered according to the assigned group; The "spinal needle" was withdrawn and the epidural catheter was inserted in a cephalic direction, leaving 5 cm inside the epidural space. The catheter was fixed to the skin with adhesive tape for later use. The patient will be placed in the supine position and a position is given with the surgical table 30 degrees to the left. Vital sign monitoring was started every 3 minutes for the first 15 minutes and then every 5 minutes until the end of the procedure. When a MAP record of less than 20% is obtained at the beginning, 10 mg ephedrine will be administered, an evaluation of the sensory block will begin 6 minutes after administering the block dose, with the prick technique, this evaluation will be It will be performed every 3 minutes during the first 15 minutes and then every 15 minutes until the end of the surgery. Simultaneously, an assessment of motor blockade will begin with a Bromage scale. After taking the second vital signs (3 minutes), the patient will be asked if she feels nauseated or if she vomits and it will be recorded. At the time of the extraction of the fetus, the Apgar score given by the neonatologist at one minute and at 5 minutes of extrauterine life will be recorded. Once the placenta has been delivered, a sample for gasometry will be taken with a heparinized syringe from the umbilical artery and sent to the laboratory for processing. A dose of local anesthetic will be administered through a 5% to 2% lidocaine epidural catheter if the patient reports discomfort or pain and the surgical procedure has not been completed. The information collected will be recorded in the data collection sheet. The sample size was calculated with a formula for comparing two means with a finite population.A pilot test was carried out with the specified criteria, which included 40 patients, 20 patients received 5 mg of subarachnoid hyperbaric bupivacaine and 20 patients received 10 mg, for the maximum arterial hypotension variable registered a standard deviation of 16.87 was obtained. The finite population was obtained by registering the total cesarean sections of the Civil Hospital of Guadalajara performed during the year 2022, which were 1,256 cesarean sections and losses of 20% are calculated, obtaining a total of 53 patients per group with a total of 106 patients. Once the sample is completed, the database will be started in the Microsoft Office Excel program, which will be exported to the statistical program Statistics Product and Service Solution (SPSS) for statistical analysis. The data obtained will be expressed through measures of central tendency and dispersion, mean, minimum, maximum, median and standard deviation for quantitative variables, and frequencies and percentages in the case of qualitative variables. The intragroup differences for the quantitative variables were performed using the Student's T test, differences between the groups were determined with the U Mann Whitney test. Qualitative variables will be analyzed with the Chi Square test. A value of p≤0.05 is considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Hospital Civil de Guadalajara
        • Contact:
        • Contact:
        • Principal Investigator:
          • MARIA DE LOS ANGELES CAMPECHANO-ASCENCIO, MSc
        • Sub-Investigator:
          • MIRIAM MENDEZ-DEL VILLAR, MSc PhD
        • Sub-Investigator:
          • LEONEL GARCIA-BENAVIDES, MSc PhD
        • Sub-Investigator:
          • JORGE BRAVO-RUBIO, MSc
        • Sub-Investigator:
          • EDY DAVID RUBIO-ARELLANO, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
Drug: 5mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
Other Names:
  • hyperbaric bupivacaine 1ml
  • bupivacaine/Dextrose 1ml
Experimental: 10mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10mg
Drug: 10mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10 mg
Other Names:
  • hyperbaric bupivacaine 2ml
  • bupivacaine/Dextrose 2ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the mean blood pressure
Time Frame: 3 hour
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
Time Frame: 3 hour
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
Time Frame: 3 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Document the Apgar score
Time Frame: 5 minutes
Document the Apgar score in the newborn. (Apgar Score evaluate five sign: color, heart rate, reflex irritability, muscle tone and respiration) The score ranges from 0 to 2 per sign according to the criteria of the neonatologist, to grant a maximum score of 10 points. A grade of less than 7 points is considered low Apgar scores. This scores is registered t minute and five minutes of life.
5 minutes
Describe the adverse effects (nausea or vomiting)
Time Frame: 3 hour
Number of pregnant patients with obesity with side effects such as nausea or vomiting after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
3 hour
Identify the level of sensory blockade
Time Frame: 15 minutes
Number of pregnant patients with obesity with adequate sensory block (thoracic dermatome 4 is defined as adequate to begin the surgical technique), the level of sensory block reached after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg. The sensory block was evaluated using pinprick. Every 3 minutes the first 15 minutes after the subarachnoid block.
15 minutes
Describe the adverse effects on the fetus
Time Frame: 1 hour
Number of pregnant patients with obesity with any side effect associated with the fetal bradycardia anesthetic technique (Fetal heart rate less than 120 beats minute) cardiac arrest (Fetal heart rate less than 100 beats minute) And in the newborn fetal acidosis (umbilical vein gasometry with Hydrogen Potential (pH) <7.0 or excess bases >-12 mmol/L)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Principal Investigator: María de los Angeles Campechano Ascencio, MSc, Hospital Civil de Guadalajara
  • Study Director: Miriam Mendez del Villar, PhD, Universidad de Guadalajara Centro Universitario de Tonalá
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 168/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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