Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Elderly Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939674
• Other study ID #: 05-2023-134
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Pusan National University Yangsan Hospital
• Contact: Jaesang BAE, MD
• Phone: 820553602129
• Email: wotkdqo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients over 65 years old scheduled for hip joint surgery

Exclusion Criteria:

• Patients with impaired consciousness or delirium before surgery

• Patients who are hemodynamically unstable before surgery

• Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function

• Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours

• Patients with known allergy to benzodiazepine, flumazenil

• Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Patients with hypersensitivity to Dextran40

• Patients who have been taking benzodiazepine for long term

• Patients with end stage renal disease requiring hemodialysis

• Patients with history of acute angle glaucoma

• Patients with alcohol or substance dependence

• ASA classification 4 or 5

Related Conditions & MeSH terms

• Elderly Patients
• Hip Joint
• Remimazolam

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in eye opening time between the two groups	Time, after stopping injection of remimazolam, to eye opening	Up to two hours
Primary	Difference in extubation time between the two groups	Time, after stopping injection of remimazolam, to extubation	Up to two hours
Secondary	Actual dose of flumazenil	Actual dose of flumazenil	Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Secondary	Occurrence of re-sedation	Richmond Agitation Sedation Scale (RASS) score of -3 or lower(Score range: -5~+4, lower score means more sedated state)	Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit
Secondary	Side effects of flumazenil usage	Number of Participants with Seizures, agitation, arrhythmias, gastrointestinal symptoms, post operative nausea and vomiting, and degree of pain	Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit