RecruitingNot ApplicableNCT05233462

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study


Sponsor

University Hospital, Caen

Enrollment

250 participants

Start Date

Feb 23, 2022

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • scheduled cesarean section with intrathecal anesthesia
  • term pregnancy \> 35 weeks
  • signed informed consent

Exclusion Criteria5

  • 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

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Interventions

OTHERstandardized dose

intrathecal anesthesia with 10 mg of bupivacaine

OTHERadjusted dose

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


Locations(1)

Caen University Hospital

Caen, France

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NCT05233462


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