Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Caen

About this trial

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

Qualifiers

scheduled cesarean section with intrathecal anesthesia

term pregnancy > 35 weeks

signed informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • standardized dose
  • adjusted dose

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators