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

March 12, 2019 updated by: Anthony Bonavia, Milton S. Hershey Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17036
        • Penn State Milton S Hershey Medical Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methohexital
Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.
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.
Other Names:
  • Brevital
Active Comparator: Propofol
Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.
Drug: 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.
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Refractory Hypotension
Time Frame: 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
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
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
Systolic Blood Pressure
Time Frame: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Systolic blood pressure will be measured through standard monitoring.
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
Diastolic blood pressure will be measured through standard monitoring.
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
Heart rate will be measured through standard monitoring.
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Anthony Bonavia, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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