Seated Time for 90% Incidence of Hypotension

Not Applicable

• Conditions: Cesarean Section Complications

• Registration Number: NCT03113045
• Lead Sponsor: Royal Victoria Hospital, Canada

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'.

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2017-03-18
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-09
• Last Update Submitted: 2017-04-09
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13
• Primary Completion: 2019-01-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hypotension	30 minutes	Presence of hypotension before delivery

Trial Locations

Locations (1)

Mcgill University Health Center; 🇨🇦 Montreal, Quebec, Canada