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

NCT05423951 | Completed DMC

• 1 other identifier: Remimazolam_OPCAB
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability

Keywords

hemodynamics; remimazolam; propofol; coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

• MAP-time integral

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

  During 10 minute from the administration of the study drug

Secondary Outcomes (13)

• Time to loss of consciousness

  During 10 minute from the administration of the study drug

• Mean blood pressure

  During 10 minute from the administration of the study drug

• Heart rate

  During 10 minute from the administration of remimazolam or propofol

• Regional cerebral oxygen saturation

  During 10 minute from the administration of the study drug

• Cardiac output

  During 10 minute from the administration of the study drug

Study Arms (2)

Remimazolam

EXPERIMENTAL

Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Rocuronium; Drug: Sufentanil

Propofol

ACTIVE COMPARATOR

Drug: Propofol; Drug: Rocuronium; Drug: Sufentanil

Interventions

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.

Also known as: Remimazolam Besylate

Remimazolam

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.

Propofol

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

Propofol; Remimazolam

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.

Propofol; Remimazolam

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Injections, Intravenous; Powders; Propofol; Rocuronium; Sufentanil

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Dosage Forms; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 21, 2022
• Study Start: July 26, 2022
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)