Status:
COMPLETED
Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans
Lead Sponsor:
University of Manitoba
Conditions:
Body Temperature Changes
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions...
Detailed Description
Body core and brain cooling by 1-3°C has been used as an adjunct in treatment of stroke and myocardial infarction (MI) patients. Body surface cooling is simple and non-invasive however this process is...
Eligibility Criteria
Inclusion
- Healthy adults, who answer "No" to all the questions on a Get Active Questionnaire (GAQ) and the "Medical Screening Questionnaire for Hypothermia Study'.
- Participants will also be interviewed to determine that they are free of any cardio- respiratory disease, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.
- Also, the study will include women of child bearing potential willing to use highly effective birth control during the trial. All women of child bearing potential will complete the "Research participant information for female subjects" and undergo a pregnancy test at screening.
Exclusion
- Anyone who gives a positive answer to any question in the GAQ or Medical Screening Questionnaire for Hypothermia Study, or who has any cardio-respiratory disease, renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure will be excluded.
- Subjects contraindicated for meperidine administration or who have any of the conditions listed below will also be excluded from the study.
- hypersensitivity to meperidine or any ingredients in the formulation
- known or suspected mechanical GI obstruction or any diseases/conditions that affect bowel transit
- suspected surgical abdomen (i.e. acute appendicitis or pancreatitis)
- severe CNS depression, head injury, increased cerebrospinal or intracranial pressure
- convulsive disorder, delirium tremens
- hypothyroidism
- prostatic hypertrophy or urethral stricture
- sickle cell anemia
- Addison's disease
- Pheochromocitoma
- Known sensitivity or intolerance to the drug metoclopramide
- Use of medications that might interact negatively with meperidine. Examples should include MAO inhibitors at the time of screening or within 14 days of screening; CNS depressants; phenytoin; cimetidine; ritonavir; aclyclovir; skeletal muscle relaxants.
- pregnant women, breastfeeding women, and women planning on becoming pregnant
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04332224
Start Date
March 1 2020
End Date
April 30 2022
Last Update
January 23 2023
Active Locations (1)
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1
211 Max Bell Centre, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2