HypotensionNCT02624050
Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs
A study testing Methohexital and Propofol in people with Hypotension and Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Anesthesia
- What is being tested?
- Methohexital and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- treated for at least 6 weeks with ACEIs or ARB
- undergoing elective surgery under general endotracheal anesthesia
- ASA Physical Class I or II
Who cannot join
- 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
Show all 9Show fewer
- significant coronary artery disease
- history of systolic heart failure
- history of renal failure (creatine level >2 mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, 17036
About this study
Official title: Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.
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.
Read the 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.
- Conditions
- Hypotension, Anesthesia
- Being tested
- Methohexital, Propofol
- Keywords
- ACEI, ARB, Hypotension, General Anesthesia, Methohexital, Propofol
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethohexitalDrug
Also called Brevital
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.
PropofolDrug
Also called Diprivan
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.
| Study group | Role | What they receive |
|---|---|---|
| Methohexital | Active comparator | Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. Receives: 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Hypotensive Events
Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Secondary outcomes (10)
Number of Participants With Refractory Hypotension
Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
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.
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Systolic Blood Pressure
Systolic blood pressure will be measured through standard monitoring.
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Diastolic Blood Pressure
Diastolic blood pressure will be measured through standard monitoring.
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Heart Rate
Heart rate will be measured through standard monitoring.
Measured: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
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
Measured: Time 0,3,5,10 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
Measured: Time 0,3,5,10 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
Measured: Time 0,3,5,10 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
Measured: Time 0,3,5,10 and 15 min following anesthetic induction
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
Measured: Time 0,3,5,10 and 15 min following anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start1 Aug 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Bonavia, Milton S. Hershey Medical Center
- Investigators
- Anthony Bonavia, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624050
- Sponsor's protocol ID
- STUDY00003830
- Status last verified
- Jan 2025
- First submitted
- 3 Dec 2015
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11133595Carter 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.
PubMed 3954922Cullen 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.
PubMed 3499095Ebert 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.
PubMed 1575340Eyraud 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.
PubMed 10320155Giudicelli 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.
PubMed 2994702Gold 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.
PubMed 3499244Komatsu 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.
PubMed 24257383Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
PubMed 7168798Mets 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.
PubMed 22854335Nielson 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.
PubMed 24464761Price 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.
PubMed 1389822
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.
- ClinicalTrials.gov ID
- NCT02624050
- Acronym / sponsor ID
- STUDY00003830
- Conditions
- Hypotension, Anesthesia
- Keywords
- ACEI, ARB, Hypotension, General Anesthesia, Methohexital, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methohexital | Active comparator | Drug: MethohexitalMethohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. |
| Propofol | Active comparator | Drug: PropofolPropofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- treated for at least 6 weeks with ACEIs or ARB
- undergoing elective surgery under general endotracheal anesthesia
- ASA Physical Class I or II
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethohexitalAlso: BrevitalBoth 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. | Drug | Methohexital |
| PropofolAlso: DiprivanBoth 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. | Drug | Propofol |
Primary outcome
Number of Participants Who Had Hypotensive Events
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure
10 secondary outcomes
Number of Participants With Refractory Hypotension
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Duration of Each Hypotension Episode
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Systolic Blood Pressure
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Diastolic Blood Pressure
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Heart Rate
Time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)
Time frame: Time 0,3,5,10 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)
Time frame: Time 0,3,5,10 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)
Time frame: Time 0,3,5,10 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
Time frame: Time 0,3,5,10 and 15 min following anesthetic induction
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension
Time frame: Time 0,3,5,10 and 15 min following anesthetic induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11133595Bertrand 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.
- Background: PubMed 3954922Carter 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.
- Background: PubMed 3499095Cullen 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.
- Background: PubMed 1575340Ebert 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.
- Background: PubMed 10320155Eyraud 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.
- Background: PubMed 2994702Giudicelli 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.
- Background: PubMed 3499244Gold 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.
- Background: PubMed 24257383Komatsu 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.
- Background: PubMed 7168798Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
- Background: PubMed 22854335Mets 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.
- Background: PubMed 24464761Nielson 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.
- Background: PubMed 1389822Price 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.
- Individual participant dataSharing planned: No
Related trials for Hypotension
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Not yet recruiting
ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age
Adverse Event, Hypotension (MeSH: D007022)
Active, not recruitingPhase 3
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Intradialytic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Bonavia, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methohexital and Propofol in people with Hypotension and Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Hypotensive Events (time frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02624050, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.