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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01862055
Acronym
SAS
Enrollment
79
Registered
2013-05-24
Start date
2011-12-31
Completion date
2014-12-31
Last updated
2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Planned Cesarean Section

Keywords

Stress, Anxiety, Cesarean Section, Spinal anesthesia, Hypotension

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Pregnant women undergoing planned cesarean section under spinal anesthesia

Design outcomes

Primary

MeasureTime 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.20 minutes

Secondary

MeasureTime frameDescription
Salivary amylase activity20 minutesMeasurement of amylase activity on a sample performed in the operating room, immediately before spinal anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026