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Clinical Trials/NCT01862055
NCT01862055
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country79 target enrollmentDecember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Planned Cesarean Section
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
79
Locations
1
Primary Endpoint
Severity of maternal hypotension assessed with the total dose of vasoactive drugs required to keep systolic blood pressure between 95-105% of preinduction values.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Salivary amylase activity(20 minutes)

Study Sites (1)

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