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ET 50 for Post Caesarean Section Spinal Hypotension (ET-50)

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ClinicalTrials.gov Identifier: NCT01561274
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.

Condition or disease Intervention/treatment Phase
Hypotension Drug: 2 ml bupivacaine Drug: 1.5 ml bupivicaine. Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Time Required to Remain Sitting After Spinal Anesthesia for 50% of Patients to Not Experience Hypotension
Study Start Date : March 2012
Primary Completion Date : March 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 2 ml bupivacaine
2 ml of 0.75% hyperbaric bupivacaine, for a total of 15 mg of bupivacaine.
Drug: 2 ml bupivacaine
2 ml bupivacaine
Active Comparator: 1.5 ml bupivicaine.
1.5 ml of 0.75% hyperbaric bupivacaine, for a total of 12.5 mg of bupivacaine.
Drug: 1.5 ml bupivicaine.
1.5 ml bupivicaine.


Outcome Measures

Primary Outcome Measures :
  1. The time required to remain sitting after spinal anesthesia [ Time Frame: start with 3 minutes after completion of spinal then we ll go up or down ]
    The time required so that 50% of patients to not experience hypotension


Secondary Outcome Measures :
  1. Bupivicaine dose [ Time Frame: We will test for blockade level till 40 min after spinal ]

    To see if ET50 is dependant on the dosage of medication given, we will determine the ET50 for 2 doses of hyperbaric bupivicaine.

    Patients will receive either 2 ml or 1.5 ml of 0.75% hyperbaric bupivacaine, for a total of 15 mg or 12.5 mg of bupivacaine respectively.



Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years or older, presenting for scheduled cesarean delivery to the C7 birthing centre.

Exclusion Criteria:

  • Unable to communicate in English or French
  • Multiple gestations
  • Patients with hypertension
  • Patients with contraindications to any drug or techniques used in the study
  • BMI > 35
Contacts and Locations

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): NCT01561274


Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Albert Moore, MD McGill University Health Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albert Moore, Assistant professor, principal investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01561274     History of Changes
Other Study ID Numbers: 11-134-SDR
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents