drugset / Trial / NCT03497364

Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors

NCT03497364 ↗

Unknown 930 enrolled Shenzhen People's Hospital
RandomizedParallel-groupDouble-blindHealth-services research

Summary

Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause enough anesthesia and obviously decrease the incidence of hypotension without prophylactical prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia was performed for pregnant women after written informed consents. The dose of bupivacaine or ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of uterine artery was monitored The sensory and motor block were evaluated. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological behavior of infant were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.

Timeline

Start
2018-05-01
Primary completion
2021-11-30
Completion
2021-11-30

Outcome

Met primary endpoint

paper The height-based dosing algorithm of bupivacaine decreased the incidence of hypotension (p = 0.004), PMID 35755061 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 1.15 ml Other
Subject Bupivacaine Other / unclassified 1.2 ml Other
Subject Bupivacaine Other / unclassified 1.25 ml Other
Subject Bupivacaine Other / unclassified 1.3 ml Other
Subject Bupivacaine Other / unclassified 1.35 ml Other
Subject Bupivacaine Other / unclassified 1.4 ml Other
Subject Bupivacaine Other / unclassified 1.45 ml Other
Subject Bupivacaine Other / unclassified 1.5 ml Other
Subject Bupivacaine Other / unclassified 1.55 ml Other
Subject Bupivacaine Other / unclassified 1.6 ml Other
Subject Bupivacaine Other / unclassified 1.65 ml Other
Subject Bupivacaine Other / unclassified 1.7 ml Other
Subject Ropivacaine Other / unclassified 1.475 ml Other
Subject Ropivacaine Other / unclassified 1.55 ml Other
Subject Ropivacaine Other / unclassified 1.625 ml Other
Subject Ropivacaine Other / unclassified 1.7 ml Other
Subject Ropivacaine Other / unclassified 1.775 ml Other
Subject Ropivacaine Other / unclassified 1.85 ml Other
Subject Ropivacaine Other / unclassified 1.925 ml Other
Subject Ropivacaine Other / unclassified 2 ml Other
Subject Ropivacaine Other / unclassified 2.075 ml Other
Subject Ropivacaine Other / unclassified 2.15 ml Other
Subject Ropivacaine Other / unclassified 2.225 ml Other
Subject Ropivacaine Other / unclassified 2.3 ml Other

Indications

No indication recorded.