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

Anesthesia Clinical Trial

Official title:

Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624050
• Other study ID #: STUDY00003830
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: March 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Hypotension

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S Hershey Medical Ctr	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Eyraud D, Brabant S, Nathalie D, Fléron 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. — View 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. — View Citation

Gold MI, Abraham EC, Herrington C. A controlled investigation of propofol, thiopentone and methohexitone. Can J Anaesth. 1987 Sep;34(5):478-83. — View 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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Secondary	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
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.	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.	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.	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Secondary	Heart Rate	Heart rate will be measured through standard monitoring.	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
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	Time 0,3,5,10 and 15 min following anesthetic induction
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	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	Time 0,3,5,10 and 15 min following anesthetic induction
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	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	Time 0,3,5,10 and 15 min following anesthetic induction