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Clinical Trials in France / NCT05233462
Recruiting Not applicable

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

NCT05233462 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-02-23
Last updated
2025-07-25

Condition(s) studied

Regional Anesthesia MorbidityCesarean Section ComplicationsLocal Anesthetic Complication

Investigational drug(s) / intervention(s)

standardized doseadjusted dose

standardized dose: intrathecal anesthesia with 10 mg of bupivacaine

adjusted dose: intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Study 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

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Caen University Hospital Caen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05233462 on ClinicalTrials.gov ↗ ← All trials in France