Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

Study Overview
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Brief Summary
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Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia

Detailed Description
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The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.

Official Title
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Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : A Randomized Controlled Trial

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital Exclusion Criteria: patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran. Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke Patients with chronic renal failure Patients with severe hepatic impairment (Child Pugh class C) Patients with American Society of Anesthesiology score III or higher Patients with hypersensitivity to propofol and soy or peanuts Epilepsy patients Patient with fat metabolism abnormality Patients with high intracranial pressure Pregnant woman Patients unable to use supraglottic airway due to poor dental condition In cases that the researcher judges to be unsuitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam based total intravenous anesthesia<br>For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil. | Drug: Remimazolam<br>* For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.<br>|
| Active Comparator: Propofol based total intravenous anesthesia<br>For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil. | Drug: Propofol<br>* For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension incidence | Incidence of hypotension (MAP <65 mmHg) from induction of anesthesia to end of surgery | from induction of anesthesia to end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of vasopressor | Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery | from induction of anesthesia to end of surgery | 
| Number of occurrences of hypotension during surgery | Number of occurrences of hypotension during surgery | from induction of anesthesia to end of surgery | 
| Type of vasopressor used | Type of vasopressor used | from induction of anesthesia to end of surgery | 
| Total dose of vasopressor used | Total dose of vasopressor used | from induction of anesthesia to end of surgery | 
| Blood pressure | Blood pressure during operation, noninvasive blood pressure is measured at lower leg | from induction of anesthesia to end of surgery | 
| Heart rate | Heart rate during operation | from induction of anesthesia to end of surgery | 
| Saturation of percutaneous oxygen (SpO2) | Saturation of percutaneous oxygen (SpO2) during operation | from induction of anesthesia to end of surgery | 
| Patient State Index (PSi) | Patient State Index (PSi) during operation | from induction of anesthesia to end of surgery | 
| Incidence of bradycardia | Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50 | from induction of anesthesia to end of surgery | 
| Severity of injection pain | Severity of injection pain of sedative(propofol or remimazolam depending on group assignment) during induction of anethesia: none/ mild/ moderate/ severe | At the start of induction of general anesthesia | 
| Incidence of intraoperative awareness | Incedence of intraoperative awareness during operation | from induction of anesthesia to end of surgery | 
| Incidence of intraoperative body movement | Incidence of intraoperative body movement during operation | from induction of anesthesia to end of surgery | 
| Incidence of use of rescue sedative agents | Incidence of use of any kinds of rescue sedative agents | from induction of anesthesia to end of surgery | 
| T ime from start of administration of sedative drug to loss of consciousness | T ime from start of administration of sedative drug to loss of consciousness | from induction of anesthesia to loss of consciousness | 
| Time from the end of administration of sedative to eye opening | Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to eye opening | from end of administration of sedative to eye opening | 
| Time from the end of administration of sedative to response to verbal command | Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to response to verbal command | from end of administration of sedative to response to verbal command | 
| Time from the end of administration of sedative to supraglottic airway removal | Time from the end of administration of sedative(propofol or remimazolam depending on group assignment) to supraglottic airway removal | from end of administration of sedative to supraglottic airway removal | 
| Duration of post anesthesia care unit stay | Duration of post anesthesia care unit stay | From entering post anesthesia care unit until leaving, post-operatively 1 hour average | 
| Total analgesic consumption for 24 hours after surgery | Total analgesic consumption for 24 hours after surgery | For 24 hours after the end of surgery | 
| Numeric rating scale score in the recovery room immediately after surgery | Numeric rating scale score in the recovery room immediately after surgery, Numeric rating scale: 0 points for no pain, 10 points for the worst pain imaginable / The higher the number, the more severe the pain | Immediate after end of surgery | 
| Incidence of nausea and vomiting within 24 hours after surgery | Incidence of nausea and vomiting within 24 hours after surgery | within 24 hours after surgery | 
| Severity of nausea and vomiting within 24 hours after surgery | Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe | within 24 hours after surgery | 
| Subjective sleep quality on the day of surgery | Subjective sleep quality on the day of surgery, Score out of 10, the higher the number, the better the quality of sleep | During the day of surgery | 
| Patient satisfaction with anesthesia | Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep | The day of operation | 
| Hospital length of stay | Hospital length of stay | From administration to discharge, average 4 days | 
| 15 item Quality of Recovery | 15 item Quality of Recovery: 15-item questionnaire about the degree of recovery after surgery, 10 points per question, total 150 points | 24 hours after surgery |