Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

NCT06449430 | Recruiting

• 1 other identifier: IMIB-ECV-2024-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections. Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• compare the success rate of external cephalic version

  Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.

  Up to 24 months.

Secondary Outcomes (8)

• ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.

  Up to 24 months.

• rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV.

  Up to 24 months

• postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV

  Up to 24 months

• rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV

  Up to 24 months

• rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.

  Up to 24 months

Study Arms (2)

Sedation with propofol

EXPERIMENTAL

Atropine 0.4 mg intravenous bolus and intravenous propofol will be administered through a continuous infusion with a target plasma concentration between 4-6 micrograms/mL maintaining a BIS between 65-75, following the protocol used by Sánchez-Romero J et al. (doi:10.3390/jcm11030489). For this, an intravenous infusion pump (Agilia SP TIVA ES, Fresenius Kabi AG, Bad Homburg, Germany) will be used. After the administration of propofol, a period of 3 minutes will be waited before starting the procedure to ensure the target plasma concentration.

Drug: Sedation with propofol

bupivacaine

ACTIVE COMPARATOR

A combined spinal-epidural anesthesia technique will be performed with a spinal dose of 5-7.5 mg of hyperbaric bupivacaine and 20 μg of intrathecal fentanyl, along with the placement of an epidural catheter, following the protocol used by Brogly N et al. in "Protocols of the Obstetric Anesthesia Section of SEDAR, 2021". After the administration of epidural anesthesia, a period of 3 minutes will be waited before starting the procedure to ensure effective anesthesia.

Drug: Spinal analgesia with bupivacaine

Interventions

Sedation with propofol DRUG

Sedation with propofol

Sedation with propofol

Spinal analgesia with bupivacaine DRUG

Spinal analgesia with bupivacaine

bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation.
• Older than 18 years.
• Non-cephalic presentation.
• Desire to attempt a vaginal birth.
• Normal blood count and coagulation prior to the intervention

You may not qualify if:

• Age under 18 years old.
• Multiple gestation.
• Cephalic presentation.
• Risk of fetal compromise.
• Unexplained active bleeding.
• Absolute contraindication for vaginal delivery (Placenta Previa)
• or more previous cesarean sections.
• Previous myomectomy with entry into the uterine cavity
• Maternal fever.
• Thrombocytopenia (\<85,000 platelets).
• Maternal spinal anomaly.
• Intolerance or allergy to Propofol or any of its components.
• Intolerance or allergy to bupivacaine or any of its components.
• Contraindication for intrathecal sedation or analgesia

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

RECRUITING

Related Publications (1)

• Sanchez-Romero J, Falcon-Arana L, Blanco-Carnero JE, Garcia-Ferreira J, Herrera-Gimenez J, Fuentes-Garcia D, Araico-Rodriguez F, Gallego-Pozuelo RM, Nieto-Diaz A, de Paco-Matallana C. Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial. Trials. 2025 Oct 9;26(1):398. doi: 10.1186/s13063-025-09105-0.

  PMID: 41068932 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Propofol; Bupivacaine

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Javier Sanchez Romero, MD

CONTACT

968 36 95 00; javier.sanchez14@um.es

Catalina De Paco Matallana, MD

CONTACT

968 36 95 00; katy.depaco@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 10, 2024
• Study Start: July 6, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

ES (1)