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Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs

Primary Purpose

Hypotension, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methohexital
Propofol
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring ACEI, ARB, Hypotension, General Anesthesia, Methohexital, Propofol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • treated for at least 6 weeks with ACEIs or ARB
  • undergoing elective surgery under general endotracheal anesthesia
  • ASA Physical Class I or II

Exclusion Criteria:

  • BMI >45kg/m^2
  • taking both ACEI and ARB
  • history of difficult intubation in the past
  • require rapid sequence induction and intubation
  • uncontrolled baseline blood pressure (SBP>180mmHg or DBP >110 mmHg) at anesthesia preoperative clinic visit
  • contraindication to the use of propofol or methohexital
  • significant coronary artery disease
  • history of systolic heart failure
  • history of renal failure (creatine level >2 mg/dL)

Sites / Locations

  • Penn State Milton S Hershey Medical Ctr

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Methohexital

Propofol

Arm Description

Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.

Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.

Outcomes

Primary Outcome Measures

Number of Participants Who Had Hypotensive Events
Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure

Secondary Outcome Measures

Number of Participants With Refractory Hypotension
Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors
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.
Systolic Blood Pressure
Systolic blood pressure will be measured through standard monitoring.
Diastolic Blood Pressure
Diastolic blood pressure will be measured through standard monitoring.
Heart Rate
Heart rate will be measured through standard monitoring.
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 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 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 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 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

Full Information

First Posted
December 3, 2015
Last Updated
March 12, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02624050
Brief Title
Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs
Official Title
Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Anesthesia
Keywords
ACEI, ARB, Hypotension, General Anesthesia, Methohexital, Propofol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methohexital
Arm Type
Active Comparator
Arm Description
Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.
Intervention Type
Drug
Intervention Name(s)
Methohexital
Other Intervention Name(s)
Brevital
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Had Hypotensive Events
Description
Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Secondary Outcome Measure Information:
Title
Number of Participants With Refractory Hypotension
Description
Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Title
Duration of Each Hypotension Episode
Description
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.
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Title
Systolic Blood Pressure
Description
Systolic blood pressure will be measured through standard monitoring.
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Title
Diastolic Blood Pressure
Description
Diastolic blood pressure will be measured through standard monitoring.
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Title
Heart Rate
Description
Heart rate will be measured through standard monitoring.
Time Frame
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Title
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)
Description
Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction
Time Frame
Time 0,3,5,10 and 15 min following anesthetic induction
Title
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)
Description
Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction
Time Frame
Time 0,3,5,10 and 15 min following anesthetic induction
Title
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)
Description
Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction
Time Frame
Time 0,3,5,10 and 15 min following anesthetic induction
Title
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
Description
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 Frame
Time 0,3,5,10 and 15 min following anesthetic induction
Title
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension
Description
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 Frame
Time 0,3,5,10 and 15 min following anesthetic induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: treated for at least 6 weeks with ACEIs or ARB undergoing elective surgery under general endotracheal anesthesia ASA Physical Class I or II Exclusion Criteria: BMI >45kg/m^2 taking both ACEI and ARB history of difficult intubation in the past require rapid sequence induction and intubation uncontrolled baseline blood pressure (SBP>180mmHg or DBP >110 mmHg) at anesthesia preoperative clinic visit contraindication to the use of propofol or methohexital significant coronary artery disease history of systolic heart failure history of renal failure (creatine level >2 mg/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Bonavia, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S Hershey Medical Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17036
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11133595
Citation
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.
Results Reference
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3954922
Citation
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.
Results Reference
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PubMed Identifier
3499095
Citation
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.
Results Reference
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PubMed Identifier
1575340
Citation
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.
Results Reference
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PubMed Identifier
10320155
Citation
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.
Results Reference
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PubMed Identifier
2994702
Citation
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.
Results Reference
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PubMed Identifier
3499244
Citation
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.
Results Reference
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PubMed Identifier
24257383
Citation
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.
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Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
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Citation
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.
Results Reference
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Citation
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.
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Citation
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Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs

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