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Completed

NCT Number: NCT01862055

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

HOPITAL BICHAT Claude Bernard

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pregnant women undergoing planned cesarean section under spinal anesthesia

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Salivary amylase activity

    Time frame: 20 minutes

    Measurement of amylase activity on a sample performed in the operating room, immediately before spinal anesthesia

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SAS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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