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Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517302-29-00
Enrollment
200
Registered
2024-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anaesthesia: comparison of spinal anaesthesia with sedation

Brief summary

Successful EMV once the procedure has been completed, i.e. a foetus in cephalic presentation.

Detailed description

Events secondary to the procedure: caesarean section for permanent bradycardia, retroplacental haematoma, rupture of membranes, Events secondary to the anaesthetic: hypotension, bradycardia, desaturation, nausea/vomiting, number of punctures greater than 11 (failure of the first spinal puncture and need for one or more others), The pain felt by the patient: assessed by VAS, Final route of delivery, Presentation at delivery

Interventions

DRUGMidazolam 1 mg/ml Solution for Injection or Infusion
DRUGBUPIVACAINE VIATRIS 20 mg/4 ml
DRUGsolution injectable pour voie intra rachidienne en ampoule

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Successful EMV once the procedure has been completed, i.e. a foetus in cephalic presentation.

Secondary

MeasureTime frame
Events secondary to the procedure: caesarean section for permanent bradycardia, retroplacental haematoma, rupture of membranes, Events secondary to the anaesthetic: hypotension, bradycardia, desaturation, nausea/vomiting, number of punctures greater than 11 (failure of the first spinal puncture and need for one or more others), The pain felt by the patient: assessed by VAS, Final route of delivery, Presentation at delivery

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026