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Seated Time for 90% Incidence of Hypotension

Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03113045
Enrollment
60
Registered
2017-04-13
Start date
2017-01-31
Completion date
2020-01-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Brief summary

The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

Detailed description

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'.

Interventions

OTHERseated time

Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.

Sponsors

Royal Victoria Hospital, Canada
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

The observer will not be made aware of the time that the patient will sit.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Patients with singleton pregnancies scheduled for elective cesarean delivery

Exclusion criteria

* BMI\>35 * Unable to communicate in study language * ASA greater than 2 * Hypertensive disease of pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Hypotension30 minutesPresence of hypotension before delivery

Countries

Canada

Contacts

Primary ContactAlbert Moore
albert.moore@mcgill.ca514 934 1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026