NCT01561274: ET-50

The Time Required to Remain Sitting After Spinal Anesthesia for 50% of Patients to Not Experience Hypotension

Completed Phase 2 Last updated 20 June 2014

What this trial tests

Phase 2 trial testing 2 ml bupivacaine in Hypotension in 50 participants. Completed in 1 May 2014.

Timeline

1 March 2012

Primary endpoint
1 March 2014

1 May 2014

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	50
Start date	1 March 2012
Primary completion	1 March 2014
Estimated completion	1 May 2014
Sites	1 location across Canada

Drugs / interventions tested

• 2 ml bupivacaine — full drug profile →
• 1.5 ml bupivicaine. — full drug profile →

Conditions studied

• Hypotension — all drugs for Hypotension →

Sponsor

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

Who can join

Adults 18 to 45, female only, with Hypotension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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 that will result in a 50% rate of hypotension.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The median effective seated time for hypotension induced by spinal anesthesia at Cesarean delivery with two doses of hyperbaric bupivacaine: a randomized up-down sequential allocation study.
   Moore A, Bourrassa-Blanchette S, El Mouallem E, Kaufman I, et al · · 2014 · cited 8× · PMID 25056277 · DOI 10.1007/s12630-014-0208-8