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Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics
Phase 4
Waitlist Available
Led By Craig J Railton, MD, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately every 5 minutes for 6 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
It is controversial whether or not patients whose Renin Angiotensin System is blocked for the treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia. The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System causes altered dose response under general anaesthesia in a dose dependant manner. The investigators wish to look for altered responses across the usual anaesthetic dosing range as measured by blood pressure and heart responses.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately every 5 minutes for 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately every 5 minutes for 6 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systemic Vascular Resistance Index (SVRI)
Secondary study objectives
Cardiac Index (CI)
Cardiac Output (CO)
Central Venous Pressure
+5 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Non ACE/ARB ExposedExperimental Treatment1 Intervention
Sevoflurane/oxygen/air/nitrous oxide
Hypertensive patients not exposed to angiotensin converting enzyme inhibitors or Angiotensin receptor blocking agents will be put into this arm.
Group II: Angiotensin Receptor Blocker ExposedExperimental Treatment1 Intervention
Sevoflurane/oxygen/air/nitrous oxide
Hypertensive patients exposed to Angiotensin Receptor Blocking Agents (ARBs).
Preoperative Exposure to any of the following Angiotensin II Receptor Blocking Agents Losartan(Cozaar) Candesartan (Atacand) Valsartan (Diovan) Irbesartan (Avapro) Telmisartan (Micardis) Eprosartan (Teveten) Olemisartan (Benicar) Azilsartan (Edarbi)
Group III: Angiotensin Converting Enzyme ExposedExperimental Treatment1 Intervention
Sevoflurane/oxygen/air/nitrous oxide
Hypertensive patients exposed to Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors)will make up this arm.
Preoperative Exposure to any of the following Angiotensin Converting Enzyme Inhibitors Enalapril (Vasotec/Renitec) Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace) Quinapril (Accupril) Perindopril (Coversyl/Aceon) Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril) Benazepril (Lotensin) Imidapril (Tanatril) Zofenopril (Zofecard) Trandolapril (Mavik/Odrik/Gopten) Fosinopril (Fositen/Monopril)
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,260 Total Patients Enrolled
University of Western Ontario, CanadaOTHER
166 Previous Clinical Trials
319,278 Total Patients Enrolled
Craig J Railton, MD, PhDPrincipal InvestigatorLawson Health Research Institute