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

Not Applicable

Completed

• Conditions: Hemodynamic Instability
• Interventions: Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Propofol; Drug: Rocuronium; Drug: Sufentanil

• Registration Number: NCT05423951
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2022-07-26
• Status Verified: 2023-11
• Primary Completion: 2023-11-08
• Study Completion: 2023-11-08
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]	-
Propofol	Rocuronium	-
Remimazolam	Rocuronium	-
Remimazolam	Sufentanil	-
Propofol	Propofol	-
Propofol	Sufentanil	-

Primary Outcome Measures

Name	Time	Method
MAP-time integral	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 Outcome Measures

Name	Time	Method
Mean blood pressure	During 10 minute from the administration of the study drug	maximum / minimum value (mmHg)
Time to loss of consciousness	During 10 minute from the administration of the study drug	The time from the study drug administration to loss of consciousness
Phenylephrine dose	During 10 minute from the administration of the study drug	Total dose of administered phenylephrine (mcg)
Study drug dose	During 10 minute from the administration of the study drug	Total dose of administered remimazolam or propofol (mg)
Ephedrine dose	During 10 minute from the administration of the study drug	Total dose of administered ephedrine (mg)
Vasopressin dose	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
Heart rate	During 10 minute from the administration of remimazolam or propofol	maximum / minimum / mean / median / time-weighted average values (bpm)
Regional cerebral oxygen saturation	During 10 minute from the administration of the study drug	continuous monitoring of regional cerebral oxygen saturation during surgery (%)
Cardiac output	During 10 minute from the administration of the study drug	continuous monitoring of cardiac output (L/min)
Sufentanil dose	During 10 minute from the administration of the study drug	Total dose of administered sufentanil (mcg)
Crystalloid	During 10 minute from the administration of the study drug	Total volume of administered crystalloid (ml)
Number of vasopressor administration	During 10 minute from the administration of the study drug	1. Total number (n); 2. Ephedrine (n); 3. Phenylephrine (n); 4. Vasopressin (n); 5. Norepinephrine (n)
Norepinephrine dose	During 10 minute from the administration of the study drug	Total dose of administered norepinephrine (mcg)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of