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ET50 With Fentanyl for Post Caesarean Section Spinal Hypotension

NCT01896960 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-06-23

No results posted yet for this study

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 and fentanyl that will result in a 50% rate of hypotension.

Conditions

Interventions

DRUG

Bupivacaine with 15 micrograms of fentanyl

Testing 2 doses of Bupivacaine (12.5 mg and 15 mg) with 15 micrograms fentanyl

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Albert Moore, MD · McGill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT01896960 on ClinicalTrials.gov