NCT01561274

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 that will result in a 50% rate of hypotension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

March 20, 2012

Last Update Submit

June 20, 2014

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • The time required to remain sitting after spinal anesthesia

    The time required so that 50% of patients to not experience hypotension

    start with 3 minutes after completion of spinal then we ll go up or down

Secondary Outcomes (1)

  • Bupivicaine dose

    We will test for blockade level till 40 min after spinal

Study Arms (2)

2 ml bupivacaine

ACTIVE COMPARATOR

2 ml of 0.75% hyperbaric bupivacaine, for a total of 15 mg of bupivacaine.

Drug: 2 ml bupivacaine

1.5 ml bupivicaine.

ACTIVE COMPARATOR

1.5 ml of 0.75% hyperbaric bupivacaine, for a total of 12.5 mg of bupivacaine.

Drug: 1.5 ml bupivicaine.

Interventions

2 ml bupivacaineDRUG

2 ml bupivacaine

2 ml bupivacaine
1.5 ml bupivicaine.DRUG

1.5 ml bupivicaine.

1.5 ml bupivicaine.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients 18 years or older, presenting for scheduled cesarean delivery to the C7 birthing centre.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Related Publications (2)

  • Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.

    PMID: 32619039DERIVED

  • Moore A, Bourrassa-Blanchette S, El Mouallem E, Kaufman I, El-Bahrawy A, Li-Pi-Shan W, Hatzakorzian R. 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. Can J Anaesth. 2014 Oct;61(10):916-21. doi: 10.1007/s12630-014-0208-8. Epub 2014 Jul 24.

    PMID: 25056277DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Albert Moore, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, principal investigator

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

CA(1)