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Hypotension | ET50 With Fentanyl for Post Caesarean Section Spinal Hypotension

Hypotension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypotension

Pregnancy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Bupivacaine with 15 micrograms of fentanylTesting 2 doses of Bupivacaine (12.5 mg and 15 mg) with 15 micrograms fentanyl

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

2 ml Bupivacaine2 ml Bupivacaine with 15 micrograms of fentanyl

1.5 ml Bupivacaine1.5 ml Bupivacaine with 15 micrograms of fentanyl

Study Status

Unknown status

Start Date: July 2013

Completed Date: June 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Sitting time to avoid hypotension

Secondary Outcome: Pain occurence

Study sponsors, principal investigator, and references

Principal Investigator: Albert Moore, MD

Lead Sponsor: McGill University Health Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01896960

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