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

Not Applicable

Completed

• Conditions: Anesthesia; Hypotension
• Interventions: Drug: Methohexital; Drug: Propofol

• Registration Number: NCT02624050
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Study Start: 2016-08-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Results First Submitted: 2019-01-20
• Results First Submitted QC: 2019-03-12
• Results First Posted: 2019-03-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methohexital	Methohexital	Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.
Propofol	Propofol	Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Hypotensive Events	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Refractory Hypotension	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
Duration of Each Hypotension Episode	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.
Systolic Blood Pressure	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction	Systolic blood pressure will be measured through standard monitoring.
Diastolic Blood Pressure	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction	Diastolic blood pressure will be measured through standard monitoring.
Heart Rate	Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction	Heart rate will be measured through standard monitoring.
Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)	Time 0,3,5,10 and 15 min following anesthetic induction	Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 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 0,3,5,10 and 15 min following anesthetic induction	Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 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 0,3,5,10 and 15 min following anesthetic induction	Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 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 0,3,5,10 and 15 min following anesthetic induction	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
Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension	Time 0,3,5,10 and 15 min following anesthetic induction	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

Trial Locations

Locations (1)

Penn State Milton S Hershey Medical Ctr; 🇺🇸 Hershey, Pennsylvania, United States