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RECRUITING
NCT05233462
NA

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Sponsor: University Hospital, Caen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2022-02-23

Completion Date

2026-12-31

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

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

Locations (1)

Caen University Hospital

Caen, France