Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Jul 2012
Longer than P75 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 23, 2017
August 1, 2017
7.5 years
October 1, 2012
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systemic Vascular Resistance Index (SVRI)
A calculated hemodyamic parameter that assesses the resistance the heart faces to the forward flow of blood. Corrected for body surface area. SVRI = (cardiac output/blood pressure)/body surface area.
approximately every 5 minutes for 6 hours
Secondary Outcomes (8)
Heart Rate
approximately every 5 minutes for 6 hours
Systolic Blood Pressure
approximately every 5 minutes for 6 hours
Diastolic Blood Pressure
approximately every 5 minutes for 6 hours
Central Venous Pressure
approximately every 5 minutes for 6 hours
Cardiac Output (CO)
approximately every 5 minutes for 6 hours
- +3 more secondary outcomes
Study Arms (3)
Angiotensin Converting Enzyme Exposed
OTHERSevoflurane/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)
Angiotensin Receptor Blocker Exposed
OTHERSevoflurane/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)
Non ACE/ARB Exposed
OTHERSevoflurane/oxygen/air/nitrous oxide Hypertensive patients not exposed to angiotensin converting enzyme inhibitors or Angiotensin receptor blocking agents will be put into this arm.
Interventions
Patients in each arm will be randomized to receive either: 50 per cent oxygen, air, and sevoflurane or 50% nitrous oxide, oxygen and sevoflurane. They will then cross over to the other gas mixture. The depth of each the anesthetic will be varied from 0.8 MAC (minimum alveolar concentration) to 1.6 MAC in 0.2 MAC steps. Hemodyamic variables will be measured at each anesthetic concentration (average of five measurements). Time will be allowed for anesthetic agent equilibration. Paralysis and analgesia using rocuronium and fentanyl will be provided to ensure patients do not move at low (less than 1.0 MAC. It is estimated the time for the cross over experiment will be approximately six hours.
Eligibility Criteria
You may qualify if:
- age over 40
- composite head and neck tumor resection
- treated hypertension
- hypertension medications taken on morning of surgery (except diuretics)
You may not qualify if:
- patient refusal
- age less than 40 or over 80 years
- combined surgical procedures
- emergency surgery
- Left ventricular ejection fraction less than 50 per cent
- calculated creatinine clearance less than 60 mL per minute
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre - Victoria Campus
London, Ontario, N6A 5W9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig J Railton, MD, PhD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 29, 2012
Study Start
July 1, 2012
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
August 23, 2017
Record last verified: 2017-08