At a glance
ClinicalIndex Comparison Record- ✓Age 18–40 years
- ✓Elective cesarean delivery
- ✓Singleton pregnancy
- ✓Gestational age >37 weeks
- ✕Twin pregnancy
- ✕History of 2 or more prior cesarean sections
- ✕Diabetes or gestational diabetes
- ✕Placenta previa
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)
In Brief
A Phase 2 clinical trial evaluating HB Prilocaine 2% (varying dose), HB Prilocaine 2%, and 2 other interventions for Pregnant Women. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
Study Details
Timeline
Interventions
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
2.5µg sufentanyl
100 µg Morphine