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Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia — RAMCES  

Cesarean Section Complications Clinical Trial

Official title:
Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05233462
Study type Interventional
Source University Hospital, Caen
Contact jean-luc hanouz, M.D, Ph.D
Phone 02 31 06 47 36
Email hanouz-jl@chu-caen.fr
Status Not yet recruiting
Phase N/A
Start date February 1, 2022
Completion date December 31, 2024
View Details
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