Pregnant patients with a planned caesarian. MedDRA version: 12.1 Level: LLT Classification code 10067385 Term: Spinal analgesia
Conditions
Interventions
Trade Name: Sufenta
Product Name: Sufenta
Pharmaceutical Form: Solution for injection
Trade Name: Fentanyl
Product Name: Fentanyl
Pharmaceutical Form: Solution for injection
Sponsors
CHU Brugmann
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years or older - planned caesarian - signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - loco-regional anesthesia not indicated or refused - sensitivity to one of the used products - participation to another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To delay the first use of morphine after intrathecal anesthesia.;Secondary Objective: - To reduce the quantity of morphine used 24h and 48h after the intrathecal anesthesia. - Safety assessment through the frequence of nausea, vomiting and pruritus 24h and 48h after the intrathecal anesthesia;Primary end point(s): Time until the first use of morphine from the intrathecal anesthesia | — |
Countries
Belgium
Outcome results
None listed