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Completed

NCT Number: NCT02624050

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

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.

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Key information

Conditions

Hypotension Anesthesia Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, 17036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Methohexital

Drug

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

Propofol

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2015
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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