Clinical trial NCT02624050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Anesthesia
Keywords: ACEI
ARB
Hypotension
General Anesthesia
Methohexital
Propofol
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants Who Had Hypotensive Events
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Secondary outcomes:
measure: Number of Participants With Refractory Hypotension
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
measure: Duration of Each Hypotension Episode
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
measure: Systolic Blood Pressure
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
measure: Diastolic Blood Pressure
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
measure: Heart Rate
timeFrame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
measure: Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)
timeFrame: Time 0,3,5,10 and 15 min following anesthetic induction
measure: Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)
timeFrame: Time 0,3,5,10 and 15 min following anesthetic induction
measure: Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)
timeFrame: Time 0,3,5,10 and 15 min following anesthetic induction
measure: 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
timeFrame: Time 0,3,5,10 and 15 min following anesthetic induction
measure: Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension
timeFrame: Time 0,3,5,10 and 15 min following anesthetic induction
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Ctr
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Anthony Bonavia, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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. doi: 10.1093/bja/69.2.172.