The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section

January 9, 2014 updated by: Geng guiqi

Maternal hypotension is a common side effect after spinal anesthesia for cesarean delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and blood pooling in blocked areas of the body respectively, are main causes of spinal anaesthesia-induced hypotension during Caesarean delivery.

Cardiac output, which has shown to be a better predictor of organ and placental perfusion than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the maternal population.This is largely because of the lack of availability of accurate and reproducible noninvasive measurement techniques. Up to now, preventing hypotension has continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as markers of cardiovascular status, because these are more easily measured.

Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension during spinal anaesthesia, would also have a positive and significant association.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6

Contacts and Locations

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

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Recruiting
        • Obstetrics & Gynecology Hospital, Fudan University
        • Contact:

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

American Society of Anesthesiologists physical status I and II patients undergoing elective cesarean delivery under combined spinal-epidural (CSE) anesthesia

Description

Inclusion Criteria:

  • full-term gestation (>36 and <41 weeks of gestation) with a singleton pregnancy

Exclusion Criteria:

  • emergency cases
  • placenta praevia
  • preeclampsia
  • cardiovascular or cerebrovascular disease
  • morbid obesity with a BMI≥40
  • contraindications to spinal anaesthesia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hypotension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
value of PetCO2 and changes in artery pressure
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2014

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

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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