ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cesarean Delivery
- Obesity Morbid
- Spinal Anesthesia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03781388
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ashraf S Habib, MD Duke University
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