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COMPLETED
NCT03781388
PHASE4

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.

Official title: ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2019-05-01

Completion Date

2022-12-06

Last Updated

2026-04-17

Healthy Volunteers

Yes

Interventions

DRUG

Bupivacaine

Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) \<0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.

Locations (1)

Duke University Hospital

Durham, North Carolina, United States