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Effect of Body Mass Index on the Dose of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section

NCT00403663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-07-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

bupivacaine 0.75% with fentanyl and morphine

the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose CA Carvalho, MD PhD · Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403663 on ClinicalTrials.gov