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

NCT02624050 | Completed Results DMC

• 1 other identifier: STUDY00003830
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Anesthesia

Keywords

ACEI; ARB; Hypotension; General Anesthesia; Methohexital; Propofol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Number of Participants With Refractory Hypotension

  Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

• Duration of Each Hypotension Episode

  Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

• Systolic Blood Pressure

  Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

• Diastolic Blood Pressure

  Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

• Heart Rate

  Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

Study Arms (2)

Methohexital

ACTIVE COMPARATOR

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

Drug: Methohexital

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

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.

Also known as: Brevital

Methohexital

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.

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, 17036, United States

Location

Related Publications (12)

• 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.

  PMID: 11133595 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.

  PMID: 3954922 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.

  PMID: 3499095 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.

  PMID: 1575340 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.

  PMID: 10320155 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.

  PMID: 2994702 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.

  PMID: 3499244 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.

  PMID: 24257383 BACKGROUND

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

  PMID: 7168798 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.

  PMID: 22854335 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.

  PMID: 24464761 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.

  PMID: 1389822 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Methohexital; Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Anthony Bonavia
• Organization: Milton S. Hershey Medical Center

abonavia@pennstatehealth.psu.edu

717-531-6140

Study Officials

• Anthony Bonavia, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: August 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: January 28, 2025
• Results First Posted: March 13, 2019

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)