NCT00403663|Completed
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Sponsor study identifier
Secondary identifiers
interventional
52
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and epidural. Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person. This study asks a simple, yet important question: does your body mass index (BMI) influence the amount of freezing medication needed for adequate CSE anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In patients with a higher BMI, freezing medication appears to spread farther (to a higher level) in the spinal fluid. When freezing is too high, it can cause unwanted side effects. Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it may be advisable to administer less freezing medication. In this study, we want to find the ideal dose of freezing medication for patients with a higher body mass index, and compare it to the dose found to be ideal for patients with normal body mass index.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 23, 2006
Actual (reported)November 27, 2006
Actual (reported)December 2007
Actual (reported)December 2007
Actual (reported)The primary outcome will be the success/failure of the block. Success meaning a sensory block level at least at T6 within 15 minutes after intrathecal injection and no requirement of any supplemental analgesic by the patient throughout the CS.
15 minutes
Upper level of sensory blockage determined by the pinprick at midaxillary line
60 minutes
VAPS during surgery
60 minutes
Dose of lidocaine 2% required as supplementation
60 minutes
Dose of IV fentanyl or ketamine required as supplementation
60 minutes
Conversion to general anesthesia
60 minutes
the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
bupivacaine 0.75% with fentanyl and morphine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Jose CA Carvalho, MD PhD
Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
52 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2006
First Posted
November 27, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section
Contact the study team to confirm eligibility.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Last Updated
July 30, 2009
Record last verified: 2009-07
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Source: ClinicalTrials.gov.
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