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

NCT ID: NCT02624050

Last Updated: 2025-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypotension Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methohexital

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

Group Type ACTIVE_COMPARATOR

Methohexital

Intervention Type 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.

Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Brevital Diprivan

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anthony Bonavia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony Bonavia, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11133595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3954922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3499095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1575340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10320155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2994702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3499244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24257383 (View on PubMed)

Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.

Reference Type BACKGROUND
PMID: 7168798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22854335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24464761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1389822 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00003830

Identifier Type: -

Identifier Source: org_study_id

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