ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Starting dose of Bupivacaine (9 mg) 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). |
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.
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Experimental: Subsequent dose
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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.
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Outcome Measures
Primary Outcome Measures
- Percent of successful blocks for induction (success induction) [10 minutes after intrathecal drug administration]
bilateral T6 sensory level to pinprick by
- Percent of successful blocks for operation (success operation) [during surgery up to 90 minutes after intrathecal injection]
successful initial sensory level without requiring additional epidural anesthetic
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiology (ASA) class 2 and 3
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English speaking
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Gestational age > 36 weeks
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Scheduled for cesarean delivery under combined spinal epidural anesthesia
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18 years or older
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BMI > 50 kg/m2
Exclusion Criteria:
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History of past or current intravenous drug or chronic opioid abuse
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Allergy or contraindication to any study medications
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Intrapartum cesarean delivery under epidural anesthesia
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Cesarean delivery under general anesthesia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Duke University Hospital | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Ashraf S Habib, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00101530