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The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.
The study will use a Biased Coin Design (BCD), up-and-down sequential method, to determine the ET90 for absence of hypotension during Cesarean delivery. In this methodology, the first patient will be assigned an a priori initial seated time. Any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. If the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). If no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: The same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). The choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seated Time | Experimental | Pts will be seated for the allocated time depending on the previous patients hypotensive response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seated time | Other | Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Presence of hypotension before delivery | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albert Moore | Contact | 514 934 1934 | 34880 | albert.moore@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Albert Moore | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mcgill University Health Center | Recruiting | Montreal | Quebec | H2T 1V5 | Canada |
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The observer will not be made aware of the time that the patient will sit.
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