ET50 With Fentanyl for Post Caesarean Section Spinal Hypotension (ET-50-Fent)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Albert Moore, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01896960
First received: July 2, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hypotension
Pregnancy
Drug: Bupivacaine with 15 micrograms of fentanyl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Time Required to Remain Sitting After Spinal Anesthesia With Fentanyl for 50% of Patients to Not Experience Hypotension.

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Sitting time to avoid hypotension [ Time Frame: one hour ] [ Designated as safety issue: No ]
    Sitting time required to avoid a drop of 20% of patient's baseline blood pressure or symptoms of hypotension in 50% of patients


Secondary Outcome Measures:
  • Pain occurence [ Time Frame: One hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 ml Bupivacaine
2 ml Bupivacaine with 15 micrograms of fentanyl
Drug: Bupivacaine with 15 micrograms of fentanyl
Testing 2 doses of Bupivacaine (12.5 mg and 15 mg) with 15 micrograms fentanyl
Active Comparator: 1.5 ml Bupivacaine
1.5 ml Bupivacaine with 15 micrograms of fentanyl
Drug: Bupivacaine with 15 micrograms of fentanyl
Testing 2 doses of Bupivacaine (12.5 mg and 15 mg) with 15 micrograms fentanyl

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896960

Contacts
Contact: Aly Elbahrawy, MD aly.elbahrawy@mail.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada
Contact: Albert Moore, MD       moore_albert@hotmail.com   
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Albert Moore, MD McGill
  More Information

No publications provided

Responsible Party: Albert Moore, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01896960     History of Changes
Other Study ID Numbers: 12-273-SDR
Study First Received: July 2, 2013
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by McGill University Health Center:
Post spinal hypotension
Cesarian Section
ET50
Bupivacaine
Fentanyl

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 21, 2014