Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam
- Conditions
- Hypotension
- Sponsor
- Seoul National University Hospital
- Locations
- 1
- Primary Endpoint
- Hypotension incidence
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Seokha Yoo
Clinical Assistant Professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
Remimazolam based total intravenous anesthesia
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
Intervention: Remimazolam
Propofol based total intravenous anesthesia
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
Intervention: Propofol
Outcomes
Primary Outcomes
Hypotension incidence
Time Frame: from induction of anesthesia to end of surgery
Incidence of hypotension (MAP \<65 mmHg) from induction of anesthesia to end of surgery
Secondary Outcomes
- Use of vasopressor(from induction of anesthesia to end of surgery)
- Number of occurrences of hypotension during surgery(from induction of anesthesia to end of surgery)
- Type of vasopressor used(from induction of anesthesia to end of surgery)
- Total dose of vasopressor used(from induction of anesthesia to end of surgery)
- Blood pressure(from induction of anesthesia to end of surgery)
- Heart rate(from induction of anesthesia to end of surgery)
- Saturation of percutaneous oxygen (SpO2)(from induction of anesthesia to end of surgery)
- Patient State Index (PSi)(from induction of anesthesia to end of surgery)
- Incidence of bradycardia(from induction of anesthesia to end of surgery)
- Severity of injection pain(At the start of induction of general anesthesia)
- Incidence of intraoperative awareness(from induction of anesthesia to end of surgery)
- Incidence of intraoperative body movement(from induction of anesthesia to end of surgery)
- Incidence of use 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(from induction of anesthesia to loss of consciousness)
- 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 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(from end of administration of sedative to supraglottic airway removal)
- Numeric rating scale score in the recovery room immediately after surgery(Immediate after end of surgery)
- Subjective sleep quality on the day of surgery(During the day of surgery)
- 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(For 24 hours after the end of 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(within 24 hours after surgery)
- Patient satisfaction with anesthesia(The day of operation)
- 15 item Quality of Recovery(24 hours after surgery)
- Hospital length of stay(From administration to discharge, average 4 days)