Hypotension
Conditions
Brief summary
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
Detailed description
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.
Interventions
DRUGRemimazolam
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
DRUGPropofol
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension incidence | from induction of anesthesia to end of surgery | Incidence of hypotension (MAP \<65 mmHg) from induction of anesthesia to end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bradycardia | from induction of anesthesia to end of surgery | Incidence of bradycardia during operation, bradycardia is defined as heart rate less than 50 |
| Severity of injection pain | At the start of induction of general anesthesia | Severity of injection pain of sedative(propofol or remimazolam depending on group assignment) during induction of anethesia: none/ mild/ moderate/ severe |
| Incidence of intraoperative awareness | from induction of anesthesia to end of surgery | Incedence of intraoperative awareness during operation |
| Incidence of intraoperative body movement | from induction of anesthesia to end of surgery | Incidence of intraoperative body movement during operation |
| Use of vasopressor | from induction of anesthesia to end of surgery | Proportion of patients using vasopressors due to hypotension from induction of anesthesia to completion of surgery |
| Number of occurrences of hypotension during surgery | from induction of anesthesia to end of surgery | Number of occurrences of hypotension during surgery |
| Type of vasopressor used | from induction of anesthesia to end of surgery | Type of vasopressor used |
| Total dose of vasopressor used | from induction of anesthesia to end of surgery | Total dose of vasopressor used |
| Blood pressure | from induction of anesthesia to end of surgery | Blood pressure during operation, noninvasive blood pressure is measured at lower leg |
| Heart rate | from induction of anesthesia to end of surgery | Heart rate during operation |
| Saturation of percutaneous oxygen (SpO2) | from induction of anesthesia to end of surgery | Saturation of percutaneous oxygen (SpO2) during operation |
| Patient State Index (PSi) | from induction of anesthesia to end of surgery | Patient State Index (PSi) during operation |
| Incidence of use of rescue sedative agents | from induction of anesthesia to end of surgery | Incidence of use of any kinds of rescue sedative agents |
| Time from the end of administration of sedative to eye opening | from 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 from the end of administration of sedative to response to verbal command | from 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 from the end of administration of sedative to supraglottic airway removal | from 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 |
| Duration of post anesthesia care unit stay | From entering post anesthesia care unit until leaving, post-operatively 1 hour average | Duration of post anesthesia care unit stay |
| Total analgesic consumption for 24 hours after surgery | For 24 hours after the end of surgery | Total analgesic consumption for 24 hours after surgery |
| Numeric rating scale score in the recovery room immediately after surgery | Immediate after end of 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 |
| Incidence of nausea and vomiting within 24 hours after surgery | within 24 hours after surgery | Incidence of nausea and vomiting within 24 hours after surgery |
| Severity of nausea and vomiting within 24 hours after surgery | within 24 hours after surgery | Severity of nausea and vomiting within 24 hours after surgery: none,. mild, moderate, severe |
| Subjective sleep quality on the day of surgery | During 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 |
| Patient satisfaction with anesthesia | The day of operation | Patient satisfaction with anesthesia, Score out of 10, the higher the number, the better the quality of sleep |
| Hospital length of stay | From administration to discharge, average 4 days | Hospital length of stay |
| 15 item Quality of Recovery | 24 hours after surgery | 15 item Quality of Recovery: 15-item questionnaire about the degree of recovery after surgery, 10 points per question, total 150 points |
| T ime from start of administration of sedative drug to loss of consciousness | from induction of anesthesia to loss of consciousness | T ime from start of administration of sedative drug to loss of consciousness |
Countries
South Korea
Outcome results
None listed