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Seated Time for 90% Incidence of Hypotension

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ClinicalTrials.gov Identifier: NCT03113045
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Albert Moore, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Other: seated time Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The observer will not be made aware of the time that the patient will sit.
Primary Purpose: Prevention
Official Title: Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Hypotension [ Time Frame: 30 minutes ]
    Presence of hypotension before delivery



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113045


Contacts
Contact: Albert Moore 514 934 1934 ext 34880 albert.moore@mcgill.ca

Locations
Canada, Quebec
Mcgill University Health Center Recruiting
Montreal, Quebec, Canada, H2T 1V5
Contact: Albert Moore    5139341934 ext 34880    moore_albert@hotmail.com   
Sponsors and Collaborators
Royal Victoria Hospital, Canada
Investigators
Principal Investigator: Albert Moore McGill University Health Center

Responsible Party: Albert Moore, Principle Investigator, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier: NCT03113045     History of Changes
Other Study ID Numbers: 15010MUHC
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases