Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia
- Conditions
- Cesarean Section ComplicationsLocal Anesthetic ComplicationRegional Anesthesia Morbidity
- Interventions
- Other: standardized doseOther: adjusted dose
- Registration Number
- NCT05233462
- Lead Sponsor
- University Hospital, Caen
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- scheduled cesarean section with intrathecal anesthesia
- term pregnancy > 35 weeks
- signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group standardized dose intrathecal administration of a solution containing * bupivacaine 10 mg * morphine 100 micrograms * sufentanil 3 micrograms individualized group adjusted dose intrathecal administration of a solution containing * bupivacaine 0.05 mg per cm of patient's height * morphine 100 micrograms * sufentanil 3 micrograms
- Primary Outcome Measures
Name Time Method rate of arterial hypotension 4 hours since the start of intrathecal bupivacaine administration 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
- Secondary Outcome Measures
Name Time Method vasopressor total dose 4 hours since the start of intrathecal bupivacaine administration total dose of vasopressor administered during intrathecal anesthesia
rate of need for general anesthesia 5 min after the end of caesarean section at newborn umbilical cord clamp rate of need for general anesthesia because of intrathecal anesthesia failure or overdose
lower limb motor block at the end of the caesarean section 5 min after the end of caesarean section at newborn umbilical cord clamp lower limb motor block at the end of the caesarean section using Bromage score
patient's comfort self evaluation 4 hours since the start of intrathecal bupivacaine administration patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable)
metameric level of intrathecal anesthesia 4 hours since the start of intrathecal bupivacaine administration clinical evaluation of the metameric level obtained during intrathecal anesthesia