Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Minimally Invasive AVR

Aortic Valve Stenosis Clinical Trial

Official title:

Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Patients Undergoing Minimally Invasive Aortic Valve Replacement Surgery : A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864625
• Other study ID #: 05-2023-105
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: 820553602129
• Email: yuvi1981[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anesthetic agents can cause hypotension, and be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse. Remimazolam is known for its hemodynamic stability compared to propofol. This study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients with severe aortic valve stenosis.

Description:

Anesthetic agents can cause hypotension due to reduced cardiac contractility and vasodilation. This can be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse in extreme cases. Remimazolam is a relatively new anesthetic agent and it is a ultra-short acting benzodiazepine with a context sensitive half time of 7.5 minutes. Remimazolam is known for its hemodynamic stability compared to propofol. Previous studies have also shown that remimazolam can be safely used in patients with severe aortic stenosis and in cardiac anesthesia induction and during cardiopulmonary bypass. However, there is no definite data on comparison of hemodynamic variables between remimazolam based total intravenous anesthesia (TIVA) and conventional propofol induction and sevoflurane maintenance anesthesia. Therefore, this study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients undergoing minimally invasive aortic valve replacement surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients over 19 years old

• Patients with severe aortic stenosis, undergoing minimally invasive aortic valve replacement surgery

Exclusion Criteria:

• Patients with known allergy to benzodiazepine, flumazenil, propofol

• Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Patients with hypersensitivity to Dextran40

• Patients who have been taking benzodiazepine for long term

• Patients with whom heart rate assessment is not accurate, such as atrial fibrillation

• Patients with end stage renal disease requiring hemodialysis

• Patients with history of acute angle glaucoma

• Patients with valve disease severity of grade III or higher, other than aortic valve

• Emergency operation

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Remimazolam

Intervention

Drug:
• Remimazolam besylate
During induction, patients allocated to the remimazolam group will receive remimazolam 6mg/kg/h with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combied with remifetanil.
• Propofol/ Sevoflurane
During induction, patients allocated to the P/S group will receive propofol 1% 1-2mg/kg with remifentanil TCI 1~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with sevoflurane and remifentanil.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of vasopressors and inotropics used.	Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.	Start of anesthesia to end of anesthesia
Secondary	Hypotension and bradycardia event duration	Hypotension and bradycardia event duration will be compared	Start of anesthesia to end of anesthesia
Secondary	Extubation time	Extubation time between the two groups will be compared	End of anesthesia to extubation
Secondary	Emergence agitation	Emergence agitation will be compared between the two groups using Riker Sedation-Agitation Scale upon arrival at ICU. The Riker Sedation-Agitation Scale uses a numeric score from 1 (unarousable) to 7 (dangerous agitation)to assess the level of patient sedation and identifies seven levels of sedation and agitation, which range from deep sedation (unarousable) to dangerous agitation.	Arrival of patient at ICU