Trials / Completed
CompletedNCT03036384
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HB Prilocaine 2% (varying dose) | 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 |
| DRUG | HB Prilocaine 2% | The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl |
| DRUG | Sufentanil | 2.5µg sufentanyl |
| DRUG | Morphine | 100 µg Morphine |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2017-01-30
- Last updated
- 2020-05-06
- Results posted
- 2020-04-20
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03036384. Inclusion in this directory is not an endorsement.