drugset / Trial / NCT03036384

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

NCT03036384

Phase 2 Completed 40 enrolled Centre Hospitalier Universitaire Saint Pierre
Non-randomizedSequentialDouble-blindTreatment

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)

Timeline

Start
2016-03
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject prilocaine Small molecule 30 mg Intrathecal
Subject prilocaine Small molecule 35 mg Intrathecal
Subject prilocaine Small molecule 40 mg Intrathecal
Subject prilocaine Small molecule 45 mg Intrathecal
Subject prilocaine Small molecule 50 mg Intrathecal
Subject prilocaine Small molecule 55 mg Intrathecal
Background Morphine Other / unclassified 100 ug
Background Sufentanil Other / unclassified 2.5 ug

Indications

No indication recorded.