Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia
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 anest
| Condition(s) | Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * scheduled cesarean section with intrathecal anesthesia * term pregnancy \> 35 weeks * signed informed consent Exclusion Criteria: * 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 |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Lead sponsor | University Hospital, Caen |
| Locations | Caen, France |
| Start date | 2022-02-23 |
| NCT ID | NCT05233462 |
| Official listing | https://clinicaltrials.gov/study/NCT05233462 |