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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• scheduled cesarean section with intrathecal anesthesia

• term pregnancy \> 35 weeks

• signed informed consent

Locations
Other Locations
France
Caen University Hospital
RECRUITING
Caen
Contact Information
Primary
jean-luc hanouz, M.D, Ph.D
hanouz-jl@chu-caen.fr
02 31 06 47 36
Backup
thérèse simonet, M.D.
simonet-t@chu-caen.fr
02 31 06 47 36
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 250
Treatments
Active_comparator: control group
intrathecal administration of a solution containing~* bupivacaine 10 mg~* morphine 100 micrograms~* sufentanil 3 micrograms
Experimental: individualized group
intrathecal administration of a solution containing~* bupivacaine 0.05 mg per cm of patient's height~* morphine 100 micrograms~* sufentanil 3 micrograms
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov

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