NCT05233462 Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia
| NCT ID | NCT05233462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Regional Anesthesia Morbidity |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2022-02-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally. To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.
Eligibility Criteria
Inclusion Criteria: * scheduled cesarean section with intrathecal anesthesia * term pregnancy \> 35 weeks * signed informed consent Exclusion Criteria: * unscheduled or emergent cesarean section * any contra indication to intrathecal anesthesia * any antihypertensive drug prescribed to control arterial pressure during pregnancy * pre-eclampsia and eclampsia * history of Marfan or Ehlers Danlos disease
Contact & Investigator
jean-luc hanouz
STUDY CHAIR
University Hospital of Caen
Frequently Asked Questions
Who can join the NCT05233462 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Regional Anesthesia Morbidity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05233462 currently recruiting?
Yes, NCT05233462 is actively recruiting participants. Contact the research team at hanouz-jl@chu-caen.fr for enrollment information.
Where is the NCT05233462 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05233462 clinical trial?
NCT05233462 is sponsored by University Hospital, Caen. The principal investigator is jean-luc hanouz at University Hospital of Caen. The trial plans to enroll 250 participants.