Seated Time for 90% Incidence of Hypotension

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Other: seated time

• 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

Arm && Interventions

Group	Intervention	Description
Seated Time	seated time	Pts will be seated for the allocated time depending on the previous patients hypotensive response

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