Trial Outcomes & Findings for Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs (NCT NCT02624050)

NCT ID: NCT02624050

Last Updated: 2025-01-28

Results Overview

Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
• Results posted on: 2025-01-28

Participant Flow

Recruitment was from 08/2016 through 08/2017 at the pre-anesthesia clinic and on the day of surgery in the pre-operative area.

Participant milestones

Measure	Methohexital Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Overall Study STARTED	26	25
Overall Study COMPLETED	20	25
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Measure	Methohexital Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Overall Study Physician Decision	4	0
Overall Study Protocol Violation	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.	Total n=45 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=20 Participants	60 years STANDARD_DEVIATION 14 • n=25 Participants	61.9 years STANDARD_DEVIATION 11.8 • n=45 Participants
Sex: Female, Male Female	7 Participants n=20 Participants	11 Participants n=25 Participants	18 Participants n=45 Participants
Sex: Female, Male Male	13 Participants n=20 Participants	14 Participants n=25 Participants	27 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Number of Participants Who Had Hypotensive Events	8 Participants	21 Participants

SECONDARY outcome

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

Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Number of Participants With Refractory Hypotension	2 Participants	5 Participants

SECONDARY outcome

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

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.

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Duration of Each Hypotension Episode	5.1 min Standard Deviation 3.7	4.8 min Standard Deviation 3.4

SECONDARY outcome

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

Systolic blood pressure will be measured through standard monitoring.

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Systolic Blood Pressure	141 mm Hg Standard Deviation 26	126 mm Hg Standard Deviation 22

SECONDARY outcome

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

Diastolic blood pressure will be measured through standard monitoring.

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Diastolic Blood Pressure	85 mm Hg Standard Deviation 12	72 mm Hg Standard Deviation 11

SECONDARY outcome

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

Heart rate will be measured through standard monitoring.

Outcome measures

Measure	Methohexital n=20 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=25 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Heart Rate	80 bpm Standard Deviation 14	76 bpm Standard Deviation 15

SECONDARY outcome

Timeframe: Time 0,3,5,10 and 15 min following anesthetic induction

Population: Blood samples were not available for some participants at some time points.

Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction

Outcome measures

Measure	Methohexital n=19 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=22 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) Time 0	205.68 pg/ml Standard Deviation 231.37	200.59 pg/ml Standard Deviation 238.26
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 3 min	175.24 pg/ml Standard Deviation 204.52	166.04 pg/ml Standard Deviation 222.77
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 5 min	212.34 pg/ml Standard Deviation 230.44	208.93 pg/ml Standard Deviation 214.20
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 10 min	179.42 pg/ml Standard Deviation 243.88	168.39 pg/ml Standard Deviation 185.79
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 15 min	173.25 pg/ml Standard Deviation 221.62	147.32 pg/ml Standard Deviation 163.66

SECONDARY outcome

Timeframe: Time 0,3,5,10 and 15 min following anesthetic induction

Population: Blood Samples were not available for some participants at some time points.

Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction

Outcome measures

Measure	Methohexital n=19 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=20 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) Time 0	70.89 pg/ml Standard Deviation 52.57	66.46 pg/ml Standard Deviation 40.82
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) 3 min	60.86 pg/ml Standard Deviation 63.46	49.87 pg/ml Standard Deviation 34.48
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) 5 min	89.85 pg/ml Standard Deviation 63.52	57.29 pg/ml Standard Deviation 31.95
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) 10 min	40.96 pg/ml Standard Deviation 36.97	44.17 pg/ml Standard Deviation 29.95
Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia) 15 min	46.28 pg/ml Standard Deviation 35.17	39.56 pg/ml Standard Deviation 27.77

SECONDARY outcome

Timeframe: Time 0,3,5,10 and 15 min following anesthetic induction

Population: Blood samples were not available for some participants at some time points

Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction

Outcome measures

Measure	Methohexital n=9 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=11 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) Time 0	21.71 pg/ml Standard Deviation 17.17	18.85 pg/ml Standard Deviation 16.15
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 3 min	19.07 pg/ml Standard Deviation 18.96	19.56 pg/ml Standard Deviation 16.84
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 5 min	21.42 pg/ml Standard Deviation 18.70	20.62 pg/ml Standard Deviation 15.54
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 10 min	24.46 pg/ml Standard Deviation 17.91	20.32 pg/ml Standard Deviation 16.87
Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) 15 min	22.16 pg/ml Standard Deviation 18.46	17.63 pg/ml Standard Deviation 16.42

SECONDARY outcome

Timeframe: Time 0,3,5,10 and 15 min following anesthetic induction

Population: Blood samples were not available for some participants at some time points

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

Outcome measures

Measure	Methohexital n=13 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=13 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
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 0	30.75 pg/ml Standard Deviation 15.13	29.76 pg/ml Standard Deviation 16.17
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 3 min	25.07 pg/ml Standard Deviation 17.41	26.50 pg/ml Standard Deviation 16.34
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 5 min	34.66 pg/ml Standard Deviation 19.12	23.99 pg/ml Standard Deviation 13.71
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 10 min	29.36 pg/ml Standard Deviation 18.28	16.37 pg/ml Standard Deviation 9.18
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 15 min	26.76 pg/ml Standard Deviation 15.00	22.15 pg/ml Standard Deviation 7.72

SECONDARY outcome

Timeframe: Time 0,3,5,10 and 15 min following anesthetic induction

Population: Blood samples were not available for some participants at some time points

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

Outcome measures

Measure	Methohexital n=2 Participants Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight. 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 n=5 Participants Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight. 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.
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension Time 0	14.85 pg/ml Standard Deviation 7.74	33.28 pg/ml Standard Deviation 28.96
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension 3 min	10.57 pg/ml	30.24 pg/ml Standard Deviation 25.13
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension 5 min	13.73 pg/ml Standard Deviation 9.83	29.89 pg/ml Standard Deviation 21.28
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension 10 min	13.93 pg/ml Standard Deviation 8.93	22.61 pg/ml Standard Deviation 12.25
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension 15 min	12.85 pg/ml Standard Deviation 1.22	63.86 pg/ml Standard Deviation 45.64

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Methohexital

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Bonavia

Milton S. Hershey Medical Center

Phone: 717-531-6140

Email: abonavia@pennstatehealth.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place