Clinical trial · Interventional
Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol
Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil Compared to Propofol-based Total Intravenous Anesthesia in Patients Undergoing Breast Cancer Surgery: a Randomized Controlled Trial
NCT05435911CI-TRIAL-00063206completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recovery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumazenil | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remimazolam with flumazenil
- description
- Patients allocated to remimazolam with flumazenil group receive remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
- interventionNames
- Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
- Drug: Flumazenil
- type
- ACTIVE_COMPARATOR
- label
- Propofol-based total intravenous anesthesia
- description
- Patients allocated to the propofol-based total intravenous anesthesia group receive propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
- interventionNames
- Drug: Propofol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient, age \>19, scheduled for breast cancer surgery under general anesthesia Exclusion Criteria: * Patients who are not alert before procedure * Day surgery * BMI ≥35 * Hemodynamicaly unstable patients before procedure * Patients with history of neromuscular disease or drug use affecting neuromuscular function. * Patients with history of adverse reaction of allergic reaction to study drugs * Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support * Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h * Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Alcohol or drug dependence * Organic brain disorder * Patients with hypersensitive to beans or peanut * Patients who refuse to participate
References
Publications (1)
- DERIVEDLee J, Kim DH, Ju JW, Nam K, Cho YJ, Jeon Y, Lee S. Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):199-207. doi: 10.1097/EJA.0000000000001951. Epub 2024 Jan 11. PMID 38205822