Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

Daegu Catholic University Medical Center

Status and phase: Completed; Phase 3

Conditions: General Anesthetics

Treatments: Drug: Anesthesia induction with remimazolam; Drug: Anesthesia induction with propofol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05635201

CR-22-138

Details and patient eligibility

About

The goal of this clinical trial is to compare the effects of changes in autonomic nervous activity on changes in blood pressure after anesthesia induction between propofol and remimazolam in patients undergoing low-risk surgery. The main questions it aims to answer are:

• Does remimazolam shift sympathovagal balance toward parasympathetic predominance less than propofol?
• Does the less shift in sympathovagal balance toward parasympathetic predominance attenuate the reduction in blood pressure? Participants will be administered either propofol or remimazolam for anesthesia induction, after which the autonomic nervous activity and blood pressure will be measured.

Researchers will compare the propofol and remimazolam groups to see if remimazolam causes less shift in sympathovagal balance toward parasympathetic predominance and subsequently attenuates the reduction in blood pressure.

Enrollment: 78 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 20 and 60 years
• American Society of Anesthesiologists physical status of 1
• Elective low-risk surgery requiring general anesthesia, the duration of which is shorter than 2 hours and 30 minutes (e.g., Laparoscopic cholecystectomy, Functional endoscopic sinus surgery, etc.)
• Body mass index less than 30 kg/m2

Exclusion criteria

• Arrhythmias or cardiac conduction disorders
• Disease or medical conditions affecting autonomic nervous activity (hypertension, diabetes mellitus, ischemic heart disease, congestive heart failure, cerebrovascular accident, chronic kidney disease, thyroid dysfunction, etc.)
• Valvular heart disease
• Use of medications affecting autonomic nervous activity or cardiac conduction (e.g., beta blocker)
• Limited mouth opening, limited head and upper neck extension, history of obstructive sleep apnea, or Modified Mallampati class 3 or 4
• Serum electrolyte abnormalities
• Severe hypovolemia
• Psychiatric diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Propofol group

Active Comparator group

Description:

Receives propofol for anesthesia induction

Treatment:

Drug: Anesthesia induction with propofol

Remimazolam group

Experimental group

Description:

Receives remimazolam for anesthesia induction

Treatment:

Drug: Anesthesia induction with remimazolam