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Completed

NCT Number: NCT05423951

Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients

Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.

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Key information

Conditions

Hemodynamic Instability

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting

Exclusion criteria

  • Patients who refuse to participate
  • Concomitant heart valve surgery or thoracic aorta surgery
  • Emergent surgery
  • Preoperative sedation
  • Intubated state
  • Patients with mechanical circulatory assist device
  • Preoperative use of inotropes or vasopressors
  • History of allergy or adverse reaction to study drugs
  • Rapid sequence intubation
  • Lactose intolerance
  • Peanut allergy

Treatment and study plan

REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]

Drug

For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.

Other names: Remimazolam Besylate

Propofol

Drug

For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.

Rocuronium

Drug

After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed

Sufentanil

Drug

During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.

Primary outcomes

  1. MAP-time integral

    Time frame: During 10 minute from the administration of the study drug

    The area under the baseline MAP (sec * mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.

Secondary outcomes

  1. Time to loss of consciousness

    Time frame: During 10 minute from the administration of the study drug

    The time from the study drug administration to loss of consciousness

  2. Mean blood pressure

    Time frame: During 10 minute from the administration of the study drug

    maximum / minimum value (mmHg)

  3. Heart rate

    Time frame: During 10 minute from the administration of remimazolam or propofol

    maximum / minimum / mean / median / time-weighted average values (bpm)

  4. Regional cerebral oxygen saturation

    Time frame: During 10 minute from the administration of the study drug

    continuous monitoring of regional cerebral oxygen saturation during surgery (%)

  5. Cardiac output

    Time frame: During 10 minute from the administration of the study drug

    continuous monitoring of cardiac output (L/min)

  6. Sufentanil dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered sufentanil (mcg)

  7. Crystalloid

    Time frame: During 10 minute from the administration of the study drug

    Total volume of administered crystalloid (ml)

  8. Study drug dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered remimazolam or propofol (mg)

  9. Number of vasopressor administration

    Time frame: During 10 minute from the administration of the study drug

    • Total number (n)
    • Ephedrine (n)
    • Phenylephrine (n)
    • Vasopressin (n)
    • Norepinephrine (n)

  10. Ephedrine dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered ephedrine (mg)

  11. Phenylephrine dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered phenylephrine (mcg)

  12. Vasopressin dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered vasopressin (unit) 2. Ephedrine: total dose / number of administration 3. Phenylephrine: total dose / number of administration 4. Vasopressin: total dose / number of administration 5. Norepinephrine: total dose / number of administration

  13. Norepinephrine dose

    Time frame: During 10 minute from the administration of the study drug

    Total dose of administered norepinephrine (mcg)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Nov 22, 2023

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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