Recruiting
Phase 2

ET50 with Fentanyl

Sponsor:

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

Code:

NCT01896960

Conditions

Hypotension

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Bupivacaine with 15 micrograms of fentanyl

Study Details

Brief 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

Hypotension

Pregnancy

Study ID

NCT01896960

Start date

Jul, 2013

Status verified date

Jun, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 2 ml Bupivacaine

2 ml Bupivacaine with 15 micrograms of fentanyl

active comparator: 1.5 ml Bupivacaine

1.5 ml Bupivacaine with 15 micrograms of fentanyl

Interventions

Bupivacaine with 15 micrograms of fentanyl

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

Primary outcome measure

  • Sitting time to avoid hypotension [ Time Frame: one hour ]

Central Contacts and Locations

Central contacts

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Albert Moore, MD

moore_albert@hotmail.com

More Information

Sponsor

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

Last update posted

Jun 23, 2014

Last verified

Jun, 2014

Keywords

  • Post spinal hypotension
  • Cesarian Section
  • ET50
  • Bupivacaine
  • Fentanyl

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2014-06-23.