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

Primary Purpose

Aortic Valve Stenosis, Remimazolam

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam besylate
Propofol/ Sevoflurane
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Remimazolam

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam

Propofol/sevoflurane

Arm Description

Induction dose of 6 mg/kg/h of remimazolam with remifentanil TCI 1~4 nanogram/mL are injected together. When patient loses consciousness, rocuronium 0.8 mg/kg is given and endotracheal intubation is performed after confirming that TOF count is less than one. Anesthesia is maintained by using remimazolam dose of 1mg/kg/h~2mg/kg/h with remifentanil to maintain optimal depth of anesthesia, which will checked by Sedline value between 25 to 50.

1% propofol 1-2mg/kg is injected with remifentanil TCI 1~4, and when patient loses consciousness, sevoflurane is started and rocuronium 0.8mg/kg is given. After confirming that TOF count is less than one, intubation is performed and anesthesia is maintained with sevoflurane and remifentanil to keep the Sedline value between 25 and 50.

Outcomes

Primary Outcome Measures

Total dose of vasopressors and inotropics used.
Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.

Secondary Outcome Measures

Hypotension and bradycardia event duration
Hypotension and bradycardia event duration will be compared
Extubation time
Extubation time between the two groups will be compared
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.

Full Information

First Posted
May 9, 2023
Last Updated
September 23, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05864625
Brief Title
Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Minimally Invasive AVR
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Remimazolam
Keywords
Aortic Valve Stenosis, Remimazolam

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
Induction dose of 6 mg/kg/h of remimazolam with remifentanil TCI 1~4 nanogram/mL are injected together. When patient loses consciousness, rocuronium 0.8 mg/kg is given and endotracheal intubation is performed after confirming that TOF count is less than one. Anesthesia is maintained by using remimazolam dose of 1mg/kg/h~2mg/kg/h with remifentanil to maintain optimal depth of anesthesia, which will checked by Sedline value between 25 to 50.
Arm Title
Propofol/sevoflurane
Arm Type
Active Comparator
Arm Description
1% propofol 1-2mg/kg is injected with remifentanil TCI 1~4, and when patient loses consciousness, sevoflurane is started and rocuronium 0.8mg/kg is given. After confirming that TOF count is less than one, intubation is performed and anesthesia is maintained with sevoflurane and remifentanil to keep the Sedline value between 25 and 50.
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Other Intervention Name(s)
Remimazolam besylate, Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol/ Sevoflurane
Other Intervention Name(s)
Fresofol 1% TM, Fresenius
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total dose of vasopressors and inotropics used.
Description
Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.
Time Frame
Start of anesthesia to end of anesthesia
Secondary Outcome Measure Information:
Title
Hypotension and bradycardia event duration
Description
Hypotension and bradycardia event duration will be compared
Time Frame
Start of anesthesia to end of anesthesia
Title
Extubation time
Description
Extubation time between the two groups will be compared
Time Frame
End of anesthesia to extubation
Title
Emergence agitation
Description
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.
Time Frame
Arrival of patient at ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Young Kim, MD, PhD
Phone
820553602129
Email
yuvi1981@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Young Kim, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Young Kim, MD, PhD
Phone
820553602129
Email
yuvi1981@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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