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
|Condition or disease||Intervention/treatment||Phase|
|Hypotension||Drug: 2 ml bupivacaine Drug: 1.5 ml bupivicaine.||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Time Required to Remain Sitting After Spinal Anesthesia for 50% of Patients to Not Experience Hypotension|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 2014|
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.
- 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
- 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.
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
|Royal Victoria Hospital|
|Montreal, Quebec, Canada|
|Principal Investigator:||Albert Moore, MD||McGill University Health Center|