Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510701-29-00

Acronym

IMIB-ECV-2024-01

Enrollment

270

Registered

2024-05-20

Start date

2024-07-04

Completion date

Unknown

Last updated

2024-05-20

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

Conditions

External Cephalic Version

Brief summary

The primary end point is the ECV outcome.

Detailed description

Secondary outcome variables are complications of ECV, urgent cesarean section during the first 24 hours after the procedure, VAS scale, postoperative pain survey, clinically relevant hypotension, nausea, vomiting.

Interventions

DRUGBupivacaína B. Braun 5 mg/ml solución inyectable

DRUGPropofol Fresenius 10 mg/ml emulsión para inyección o perfusión

DRUGFentanest 0

DRUG05 mg/ml solución inyectable

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Secondary

Measure	Time frame
Secondary outcome variables are complications of ECV, urgent cesarean section during the first 24 hours after the procedure, VAS scale, postoperative pain survey, clinically relevant hypotension, nausea, vomiting.	—

Primary

Measure	Time frame
The primary end point is the ECV outcome.	—

Countries

Spain

Outcome results

None listed

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