NCT01896960

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

July 2, 2013

Last Update Submit

June 20, 2014

Conditions

HypotensionPregnancy

Keywords

Post spinal hypotensionCesarian SectionET50BupivacaineFentanyl

Outcome Measures

Primary Outcomes (1)

  • Sitting time to avoid hypotension

    Sitting time required to avoid a drop of 20% of patient's baseline blood pressure or symptoms of hypotension in 50% of patients

    one hour

Secondary Outcomes (1)

  • Pain occurence

    One hour

Study Arms (2)

2 ml Bupivacaine

ACTIVE COMPARATOR

2 ml Bupivacaine with 15 micrograms of fentanyl

Drug: Bupivacaine with 15 micrograms of fentanyl

1.5 ml Bupivacaine

ACTIVE COMPARATOR

1.5 ml Bupivacaine with 15 micrograms of fentanyl

Drug: Bupivacaine with 15 micrograms of fentanyl

Interventions

Bupivacaine with 15 micrograms of fentanylDRUG

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

1.5 ml Bupivacaine2 ml Bupivacaine

Eligibility Criteria

Age18 Years - 50 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

RECRUITING

Related Publications (1)

  • Moore A, El-Mouallem E, El-Bahrawy A, Kaufman I, Moustafa M, Derzi S, Hatzakorzian R, Lipishan W. An up-down determination of the required seated duration after intrathecal injection of bupivacaine and fentanyl for the prevention of hypotension during Cesarean delivery. Can J Anaesth. 2017 Oct;64(10):1002-1008. doi: 10.1007/s12630-017-0931-z. Epub 2017 Jul 24.

    PMID: 28741272DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Albert Moore, MD

    McGill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly Elbahrawy, MD

CONTACT

aly.elbahrawy@mail.mcgill.ca

Study Design

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

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 11, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

CA(1)