Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796328
Recruitment Status : Terminated (Results Invalid, study closed, analysis cannot proceed.)
First Posted : November 24, 2008
Results First Posted : April 21, 2014
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
Ronald George, IWK Health Centre

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Spinal Induced Hypotension in Cesarean Delivery
Intervention: Drug: Phenylephrine infusion

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Six subjects were withdrawn from the study

Reporting Groups
Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design

Participant Flow:   Overall Study
    Phenylephrine Infusion
experienced hypotension requiring tx                6 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design

Baseline Measures
   Phenylephrine Infusion 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      46 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      46 100.0% 
Male      0   0.0% 

  Outcome Measures

1.  Primary:   Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension   [ Time Frame: Spinal administration until delivery ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Ron George
Organization: IWK Health Centre
phone: 470-6627

Responsible Party: Ronald George, IWK Health Centre Identifier: NCT00796328     History of Changes
Other Study ID Numbers: IWK-4462-2008
First Submitted: November 19, 2008
First Posted: November 24, 2008
Results First Submitted: March 14, 2014
Results First Posted: April 21, 2014
Last Update Posted: April 23, 2018