Clinical trial NCT05375747: Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery
Official title: Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypotension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Hypotension incidence
timeFrame: from induction of anesthesia to end of surgery
Secondary outcomes:
measure: Use of vasopressor
timeFrame: from induction of anesthesia to end of surgery
measure: Number of occurrences of hypotension during surgery
timeFrame: from induction of anesthesia to end of surgery
measure: Type of vasopressor used
timeFrame: from induction of anesthesia to end of surgery
measure: Total dose of vasopressor used
timeFrame: from induction of anesthesia to end of surgery
measure: Blood pressure
timeFrame: from induction of anesthesia to end of surgery
measure: Heart rate
timeFrame: from induction of anesthesia to end of surgery
measure: Saturation of percutaneous oxygen (SpO2)
timeFrame: from induction of anesthesia to end of surgery
measure: Patient State Index (PSi)
timeFrame: from induction of anesthesia to end of surgery
measure: Incidence of bradycardia
timeFrame: from induction of anesthesia to end of surgery
measure: Severity of injection pain
timeFrame: At the start of induction of general anesthesia
measure: Incidence of intraoperative awareness
timeFrame: from induction of anesthesia to end of surgery
measure: Incidence of intraoperative body movement
timeFrame: from induction of anesthesia to end of surgery
measure: Incidence of use of rescue sedative agents
timeFrame: from induction of anesthesia to end of surgery
measure: T ime from start of administration of sedative drug to loss of consciousness
timeFrame: from induction of anesthesia to loss of consciousness
measure: Time from the end of administration of sedative to eye opening
timeFrame: from end of administration of sedative to eye opening
measure: Time from the end of administration of sedative to response to verbal command
timeFrame: from end of administration of sedative to response to verbal command
measure: Time from the end of administration of sedative to supraglottic airway removal
timeFrame: from end of administration of sedative to supraglottic airway removal
measure: Duration of post anesthesia care unit stay
timeFrame: From entering post anesthesia care unit until leaving, post-operatively 1 hour average
measure: Total analgesic consumption for 24 hours after surgery
timeFrame: For 24 hours after the end of surgery
measure: Numeric rating scale score in the recovery room immediately after surgery
timeFrame: Immediate after end of surgery
measure: Incidence of nausea and vomiting within 24 hours after surgery
timeFrame: within 24 hours after surgery
measure: Severity of nausea and vomiting within 24 hours after surgery
timeFrame: within 24 hours after surgery
measure: Subjective sleep quality on the day of surgery
timeFrame: During the day of surgery
measure: Patient satisfaction with anesthesia
timeFrame: The day of operation
measure: Hospital length of stay
timeFrame: From administration to discharge, average 4 days
measure: 15 item Quality of Recovery
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seokha Yoo
role: PRINCIPAL_INVESTIGATOR
References: