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.
The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section * a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms * a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure. Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
250
intrathecal anesthesia with 10 mg of bupivacaine
intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height
Caen University Hospital
Caen, France
RECRUITINGrate of arterial hypotension
rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks
Time frame: 4 hours since the start of intrathecal bupivacaine administration
vasopressor total dose
total dose of vasopressor administered during intrathecal anesthesia
Time frame: 4 hours since the start of intrathecal bupivacaine administration
metameric level of intrathecal anesthesia
clinical evaluation of the metameric level obtained during intrathecal anesthesia
Time frame: 4 hours since the start of intrathecal bupivacaine administration
lower limb motor block at the end of the caesarean section
lower limb motor block at the end of the caesarean section using Bromage score
Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp
rate of need for general anesthesia
rate of need for general anesthesia because of intrathecal anesthesia failure or overdose
Time frame: 5 min after the end of caesarean section at newborn umbilical cord clamp
patient's comfort self evaluation
patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable)
Time frame: 4 hours since the start of intrathecal bupivacaine administration
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