Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

Seoul National University

Status: Withdrawn

Conditions: Hypotension

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05375747

2112-150-1286

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Remimazolam based total intravenous anesthesia

Experimental group

Description:

For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.

Treatment:

Drug: Remimazolam

Propofol based total intravenous anesthesia

Active Comparator group

Description:

For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.

Treatment:

Drug: Propofol