Acute Preoperative Stress and Hypotension After Spinal Anesthesia. SAS for "Salivary Amylase and Stress " (SAS)

March 6, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Effect of Acute Preoperative Stress Assessed With Salivary Amylase on the Severity of Maternal Hypotension After Spinal Anesthesia for Planned Cesarean Section

Spinal anesthesia is the technique of choice for planned cesarean section. It is associated with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by maternal stress that can be measured with salivary amylase. The goal of this study is to assess the relationship between salivary amylase and severity of maternal hypotension after spinal anesthesia for planned cesarean section.

Study Overview

Status

Completed

Conditions

Detailed Description

Salivary amylase, heart rate variability, Spielberger state-trait inventory are assessed on the morning of surgery, on the surgical ward, and repeated in the operating room, before performing spinal anesthesia. Spinal anesthesia use hyperbaric bupivacaine (11 mg), sufentanil (5 µg) and morphine (100 µg). Prophylactic treatment of hypotension uses a continuous infusion of ephedrine (0.6 mg/ml) and phenylephrine (10 µg/ml). Rate of the continuous infusion is adapted to keep maternal systolic blood pressure between 95-105% of preinduction values. Total dose of ephedrine and phenylephrine infused from spinal anesthesia to delivery of the newborn is recorded (about 20 minutes for the estimated time frame). Association between stress markers and total dose of vasoactive drugs will be tested with the Spearman's correlation coefficient.

The study is observational. The subjects do receive a therapeutic intervention but the investigator does not assign patients to this intervention since this intervention is a routine care (spinal anesthesia for planned cesarian section) that would have been performed in the absence of the study.

Study Type

Observational

Enrollment (Actual)

79

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

  • France
      • Paris, France, 75018
        • Hopital Bichat Claude Bernard

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women undergoing planned cesarean section

Description

Pregnant women undergoing planned cesarean section under spinal anesthesia

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
SAS cohort
Consecutive patients undergoing planned cesarean section under spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of maternal hypotension assessed with the total dose of vasoactive drugs required to keep systolic blood pressure between 95-105% of preinduction values.
Time Frame: 20 minutes
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary amylase activity
Time Frame: 20 minutes
Measurement of amylase activity on a sample performed in the operating room, immediately before spinal anesthesia
20 minutes

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Dan Longrois, MD, PhD, Assistance Publique - Hôpitaux de Paris

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

December 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 10010-NI09032
  • 2011-A00284-37 (REGISTRY: ID-RCB)

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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