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Patient undergoing general anesthesia in elective surgery will be assigned to receive either methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes of induction will be compared between the groups to ascertain which drug is less likely to cause a hypotensive event.
Patients taking angiotensin converting-enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are susceptible to hypotensive events during general anesthesia. The purpose of this study is to determine if the use of either methohexital or propofol general anesthesias is more likely to result in hypotensive events in these patients during their induction. Hemodynamic metrics like blood pressure, mean arterial pressure, and heart rate will be monitored during the induction process, under both drugs, for use as the main metrics, as well as the need for vasopressors in response to patient hypotension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methohexital | Active Comparator | Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. |
|
| Propofol | Active Comparator | Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methohexital | Drug | Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Hypotensive Events | Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Refractory Hypotension | Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Duration of Each Hypotension Episode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bonavia, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S Hershey Medical Ctr | Hershey | Pennsylvania | 17036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11133595 | Background | Bertrand M, Godet G, Meersschaert K, Brun L, Salcedo E, Coriat P. Should the angiotensin II antagonists be discontinued before surgery? Anesth Analg. 2001 Jan;92(1):26-30. doi: 10.1097/00000539-200101000-00006. | |
| 3954922 | Background | Carter JA, Clarke TN, Prys-Roberts C, Spelina KR. Restoration of baroreflex control of heart rate during recovery from anaesthesia. Br J Anaesth. 1986 Apr;58(4):415-21. doi: 10.1093/bja/58.4.415. |
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Recruitment was from 08/2016 through 08/2017 at the pre-anesthesia clinic and on the day of surgery in the pre-operative area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methohexital | Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
| FG001 | Propofol | Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methohexital | Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Hypotensive Events | Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure | Posted | Count of Participants | Participants | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
|
1 year, 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Bonavia | Milton S. Hershey Medical Center | 717-531-6140 | abonavia@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | Jan 15, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2017 | Jan 15, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008723 | Methohexital |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Propofol | Drug | Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
|
|
This is the length of time that systolic blood pressure was either: (1) < 85 mmHg, or (2) a decrease of more than 30% from the individual's baseline SBP. |
| Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Systolic Blood Pressure | Systolic blood pressure will be measured through standard monitoring. | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Diastolic Blood Pressure | Diastolic blood pressure will be measured through standard monitoring. | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Heart Rate | Heart rate will be measured through standard monitoring. | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
| Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) | Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Time 0,3,5,10 and 15 min following anesthetic induction |
| Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) | Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Time 0,3,5,10 and 15 min following anesthetic induction |
| Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) | Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Time 0,3,5,10 and 15 min following anesthetic induction |
| Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension | Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction determined for participants who did not receive AVP for refractory hypotension | Time 0,3,5,10 and 15 min following anesthetic induction |
| Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension | Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min), following anesthetic induction, determined for Participants who did not receive AVP for refractory hypotension | Time 0,3,5,10 and 15 min following anesthetic induction |
| 3499095 | Background | Cullen PM, Turtle M, Prys-Roberts C, Way WL, Dye J. Effect of propofol anesthesia on baroreflex activity in humans. Anesth Analg. 1987 Nov;66(11):1115-20. |
| 1575340 | Background | Ebert TJ, Muzi M, Berens R, Goff D, Kampine JP. Sympathetic responses to induction of anesthesia in humans with propofol or etomidate. Anesthesiology. 1992 May;76(5):725-33. doi: 10.1097/00000542-199205000-00010. |
| 10320155 | Background | Eyraud D, Brabant S, Nathalie D, Fleron MH, Gilles G, Bertrand M, Coriat P. Treatment of intraoperative refractory hypotension with terlipressin in patients chronically treated with an antagonist of the renin-angiotensin system. Anesth Analg. 1999 May;88(5):980-4. doi: 10.1097/00000539-199905000-00003. |
| 2994702 | Background | Giudicelli JF, Berdeaux A, Edouard A, Richer C, Jacolot D. The effect of enalapril on baroreceptor mediated reflex function in normotensive subjects. Br J Clin Pharmacol. 1985 Sep;20(3):211-8. doi: 10.1111/j.1365-2125.1985.tb05063.x. |
| 3499244 | Background | Gold MI, Abraham EC, Herrington C. A controlled investigation of propofol, thiopentone and methohexitone. Can J Anaesth. 1987 Sep;34(5):478-83. doi: 10.1007/BF03014354. |
| 24257383 | Background | Komatsu R, You J, Mascha EJ, Sessler DI, Kasuya Y, Turan A. Anesthetic induction with etomidate, rather than propofol, is associated with increased 30-day mortality and cardiovascular morbidity after noncardiac surgery. Anesth Analg. 2013 Dec;117(6):1329-37. doi: 10.1213/ANE.0b013e318299a516. |
| 7168798 | Background | Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74. |
| 22854335 | Background | Mets B. Management of hypotension associated with angiotensin-axis blockade and general anesthesia administration. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):156-67. doi: 10.1053/j.jvca.2012.06.014. Epub 2012 Jul 31. No abstract available. |
| 24464761 | Background | Nielson E, Hennrikus E, Lehman E, Mets B. Angiotensin axis blockade, hypotension, and acute kidney injury in elective major orthopedic surgery. J Hosp Med. 2014 May;9(5):283-8. doi: 10.1002/jhm.2155. Epub 2014 Jan 24. |
| 1389822 | Background | Price ML, Millar B, Grounds M, Cashman J. Changes in cardiac index and estimated systemic vascular resistance during induction of anaesthesia with thiopentone, methohexitone, propofol and etomidate. Br J Anaesth. 1992 Aug;69(2):172-6. doi: 10.1093/bja/69.2.172. |
| BG001 |
| Propofol |
Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. Propofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Secondary | Number of Participants With Refractory Hypotension | Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors | Posted | Count of Participants | Participants | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
|
|
|
|
| Secondary | Duration of Each Hypotension Episode | This is the length of time that systolic blood pressure was either: (1) < 85 mmHg, or (2) a decrease of more than 30% from the individual's baseline SBP. | Posted | Mean | Standard Deviation | min | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure will be measured through standard monitoring. | Posted | Mean | Standard Deviation | mm Hg | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure will be measured through standard monitoring. | Posted | Mean | Standard Deviation | mm Hg | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
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| Secondary | Heart Rate | Heart rate will be measured through standard monitoring. | Posted | Mean | Standard Deviation | bpm | Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction |
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| Secondary | Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) | Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Blood samples were not available for some participants at some time points. | Posted | Mean | Standard Deviation | pg/ml | Time 0,3,5,10 and 15 min following anesthetic induction |
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| Secondary | Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) | Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Blood Samples were not available for some participants at some time points. | Posted | Mean | Standard Deviation | pg/ml | Time 0,3,5,10 and 15 min following anesthetic induction |
|
|
|
| Secondary | Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) | Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction | Blood samples were not available for some participants at some time points | Posted | Mean | Standard Deviation | pg/ml | Time 0,3,5,10 and 15 min following anesthetic induction |
|
|
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| Secondary | Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension | Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction determined for participants who did not receive AVP for refractory hypotension | Blood samples were not available for some participants at some time points | Posted | Mean | Standard Deviation | pg/ml | Time 0,3,5,10 and 15 min following anesthetic induction |
|
|
|
| Secondary | Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension | Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min), following anesthetic induction, determined for Participants who did not receive AVP for refractory hypotension | Blood samples were not available for some participants at some time points | Posted | Mean | Standard Deviation | pg/ml | Time 0,3,5,10 and 15 min following anesthetic induction |
|
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Methohexital | Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. Methohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006571 |
| Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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