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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423951
• Other study ID #: Remimazolam_OPCAB
• Status: Completed
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
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.
• Propofol
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
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
During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to loss of consciousness	The time from the study drug administration to loss of consciousness	During 10 minute from the administration of the study drug
Secondary	Mean blood pressure	maximum / minimum value (mmHg)	During 10 minute from the administration of the study drug
Secondary	Heart rate	maximum / minimum / mean / median / time-weighted average values (bpm)	During 10 minute from the administration of remimazolam or propofol
Secondary	Regional cerebral oxygen saturation	continuous monitoring of regional cerebral oxygen saturation during surgery (%)	During 10 minute from the administration of the study drug
Secondary	Cardiac output	continuous monitoring of cardiac output (L/min)	During 10 minute from the administration of the study drug
Secondary	Sufentanil dose	Total dose of administered sufentanil (mcg)	During 10 minute from the administration of the study drug
Secondary	Crystalloid	Total volume of administered crystalloid (ml)	During 10 minute from the administration of the study drug
Secondary	Study drug dose	Total dose of administered remimazolam or propofol (mg)	During 10 minute from the administration of the study drug
Secondary	Number of vasopressor administration	Total number (n); Ephedrine (n); Phenylephrine (n); Vasopressin (n); Norepinephrine (n)	During 10 minute from the administration of the study drug
Secondary	Ephedrine dose	Total dose of administered ephedrine (mg)	During 10 minute from the administration of the study drug
Secondary	Phenylephrine dose	Total dose of administered phenylephrine (mcg)	During 10 minute from the administration of the study drug
Secondary	Vasopressin dose	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	During 10 minute from the administration of the study drug
Secondary	Norepinephrine dose	Total dose of administered norepinephrine (mcg)	During 10 minute from the administration of the study drug