Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT05233462

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Led by University Hospital, Caen · Updated on 2025-07-25

250

Participants Needed

1

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled cesarean section with intrathecal anesthesia
  • Term pregnancy more than 35 weeks
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unscheduled or emergency cesarean section
  • Any contraindication to intrathecal anesthesia
  • Use of antihypertensive drugs during pregnancy
  • Presence of pre-eclampsia or eclampsia
  • History of Marfan or Ehlers Danlos disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Caen University Hospital

Caen, France

Actively Recruiting

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Research Team

J

jean-luc hanouz, M.D, Ph.D

CONTACT

T

thérèse simonet, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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