NCT05939674

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.

Detailed description

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended. However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation. Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration. Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery

Conditions

• Flumazenil Adverse Reaction
• Remimazolam
• Hip Joint
• Elderly Patients

Interventions

Type	Name	Description
DRUG	Flumazenil	During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.3mg of flumazenil according to allocated groups.
DRUG	normal saline	During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.9% normal saline according to allocated groups.

Timeline

• Start date: 2023-09-19
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2023-07-11
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea