Seated Time for 90% Incidence of Hypotension

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

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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: seated time

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2T 1V5
      • Recruiting
      • McGill University Health Center
      • Contact: Albert Moore; Phone Number: 34880 5139341934; Email: moore_albert@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seated Time; Pts will be seated for the allocated time depending on the previous patients hypotensive response	Other: seated time; Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Presence of hypotension before delivery	30 minutes

Collaborators and Investigators

• Sponsor: Royal Victoria Hospital, Canada
• Investigators: Principal Investigator: Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: March 18, 2017
• First Submitted That Met QC Criteria: April 9, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 15010MUHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No