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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
standardized dose
Other interventionintrathecal anesthesia with 10 mg of bupivacaine
adjusted dose
Other interventionintrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: control groupActive comparator 1 intervention
Group B: individualized groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
rate 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 administrationSecondary outcomes
1
vasopressor total dose
total dose of vasopressor administered during intrathecal anesthesia
Time frame
4 hours since the start of intrathecal bupivacaine administration2
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 administration3
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 clamp4
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 clampSponsors and contacts
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Source ClinicalTrials.gov