Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
Seoul National University Hospital
Seoul, South Korea
Hypotension incidence
Incidence of hypotension (MAP \<65 mmHg) from induction of anesthesia to end of surgery
Time frame: from induction of anesthesia to end of surgery
Use of vasopressor
Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery
Time frame: from induction of anesthesia to end of surgery
Number of occurrences of hypotension during surgery
Number of occurrences of hypotension during surgery
Time frame: from induction of anesthesia to end of surgery
Type of vasopressor used
Type of vasopressor used
Time frame: from induction of anesthesia to end of surgery
Total dose of vasopressor used
Total dose of vasopressor used
Time frame: from induction of anesthesia to end of surgery
Blood pressure
Blood pressure during operation, noninvasive blood pressure is measured at lower leg
Time frame: from induction of anesthesia to end of surgery
Heart rate
Heart rate during operation
Time frame: from induction of anesthesia to end of surgery
Saturation of percutaneous oxygen (SpO2)
Saturation of percutaneous oxygen (SpO2) during operation
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Time frame: from induction of anesthesia to end of surgery
Patient State Index (PSi)
Patient State Index (PSi) during operation
Time frame: 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
Time frame: 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
Time frame: At the start of induction of general anesthesia
Incidence of intraoperative awareness
Incedence of intraoperative awareness during operation
Time frame: from induction of anesthesia to end of surgery
Incidence of intraoperative body movement
Incidence of intraoperative body movement during operation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from end of administration of sedative to supraglottic airway removal
Duration of post anesthesia care unit stay
Duration of post anesthesia care unit stay
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The day of operation
Hospital length of stay
Hospital length of stay
Time frame: 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
Time frame: 24 hours after surgery