Clinical trial NCT05423951: Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients
Official title: Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Keywords: hemodynamics
remimazolam
propofol
coronary artery bypass grafting
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: MAP-time integral
timeFrame: During 10 minute from the administration of the study drug
Secondary outcomes:
measure: Time to loss of consciousness
timeFrame: During 10 minute from the administration of the study drug
measure: Mean blood pressure
timeFrame: During 10 minute from the administration of the study drug
measure: Heart rate
timeFrame: During 10 minute from the administration of remimazolam or propofol
measure: Regional cerebral oxygen saturation
timeFrame: During 10 minute from the administration of the study drug
measure: Cardiac output
timeFrame: During 10 minute from the administration of the study drug
measure: Sufentanil dose
timeFrame: During 10 minute from the administration of the study drug
measure: Crystalloid
timeFrame: During 10 minute from the administration of the study drug
measure: Study drug dose
timeFrame: During 10 minute from the administration of the study drug
measure: Number of vasopressor administration
timeFrame: During 10 minute from the administration of the study drug
measure: Ephedrine dose
timeFrame: During 10 minute from the administration of the study drug
measure: Phenylephrine dose
timeFrame: During 10 minute from the administration of the study drug
measure: Vasopressin dose
timeFrame: During 10 minute from the administration of the study drug
measure: Norepinephrine dose
timeFrame: During 10 minute from the administration of the study drug
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: