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Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

NCT ID: NCT05375747

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2023-01-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remimazolam based total intravenous anesthesia

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

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

Propofol based total intravenous anesthesia

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Remimazolam

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seokha Yoo

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seokha Yoo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2112-150-1286

Identifier Type: -

Identifier Source: org_study_id