Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery

NCT05375747 | Withdrawn DMC

• 1 other identifier: 2112-150-1286
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Hypotension incidence

  Incidence of hypotension (MAP \<65 mmHg) from induction of anesthesia to end of surgery

  from induction of anesthesia to end of surgery

Secondary Outcomes (26)

• 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

Study Arms (2)

Remimazolam based total intravenous anesthesia

EXPERIMENTAL

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

Drug: Remimazolam

Propofol based total intravenous anesthesia

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Remimazolam DRUG

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

Remimazolam based total intravenous anesthesia

Propofol DRUG

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

Propofol based total intravenous anesthesia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Hypotension

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Seokha Yoo

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 17, 2022
• Study Start: June 13, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)