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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02032355
• Other study ID #: 61538
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: January 9, 2014
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carbon Dioxide
• Hypotension

Intervention

Procedure:
• spinal anesthesia

Locations

Country	Name	City	State
China	Obstetrics & Gynecology Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Geng guiqi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of PetCO2 and changes in artery pressure		up to 4 weeks	Yes