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

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Penn State Health

Status

Completed

Conditions

Hypotension
Anesthesia

Treatments

Drug: Propofol
Drug: Methohexital

Study type

Interventional

Funder types

Other

Identifiers

NCT02624050
STUDY00003830

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 2 patient groups

Methohexital
Active Comparator group
Description:
Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.
Treatment:
Drug: Methohexital
Propofol
Active Comparator group
Description:
Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.
Treatment:
Drug: Propofol

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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