NCT05233462

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Regional Anesthesia Morbidity
• Cesarean Section Complications
• Local Anesthetic Complication

Interventions

Type	Name	Description
OTHER	standardized dose	intrathecal anesthesia with 10 mg of bupivacaine
OTHER	adjusted dose	intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Timeline

• Start date: 2022-02-23
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-02-10
• Last updated: 2025-07-25

Locations

1 site across 1 country: France