Flumazenil rapidly antagonizes benzodiazepines (BZDs); it may induce agitation, seizure, or delirium, especially when applied to patients who have taken BZDs for a long time. On the contrary, it may help patients regain consciousness in a stable and calm state by appropriately reversing the central nervous system depressant effects of BZDs. In this study, we aim to investigate the impact of flumazenil on the emergence delirium in patients anesthetized with remimazolam, the short-acting BZD drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
68
After cessation of remimazolam infusion, flumazenil 0.2 mg is administered intravenously over 15 seconds. If consciousness is not adequately restored within 3-5 minutes, a second dose of 0.1 mg intravenously over 15 seconds is administered. If necessary, 0.1 mg may be administered repeatedly at 3-5 minute intervals, and the maximum dose of 1 mg should not be exceeded.
Korea University Guro Hospital
Seoul, South Korea
Incidence of emergence delirium
Richmond Agitation \& Sedation Scale (RASS) ≥1 is considered emergence delirium.
Time frame: From emergence to postanesthesia care unit (PACU) discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery]
Incidence of postoperative delirium (POD)
3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) is used for the evaluation of POD.
Time frame: From PACU to postoperative day 5(until the discharge date if discharged before 5 days after surgery) [2 times a day in the morning/afternoon]
Severity of POD
CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs.
Time frame: From PACU to postoperative day 5
Duration of POD
3D-CAM is utilized to check the duration of POD.
Time frame: From PACU to postoperative day 5
Level of consciousness
Richmond Agitation \& Sedation Scale (RASS) is used to evaluate the patients level of consciousness.
Time frame: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Incidence of resedation
Richmond Agitation \& Sedation Scale (RASS) ≤-2 is diagnosed as resedation.
Time frame: From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery
Time to eye-opening
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam.
Time frame: After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation]
Time to extubation
Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation.
Time frame: After remimazolam cessation to extubation [within 30 min after remimazolam cessation]
Preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery
Time frame: 1 day before surgery
Postoperative nausea/vomiting (PONV)
Confirm PONV through patient's symptoms and signs.
Time frame: From immediately after extubation to PACU discharge [within 2 hours after surgery]
Postoperative pain
Numeric rating scale (NRS) or Visual analogue scale (VAS) is used to determine the patient's pain severity (\*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain)
Time frame: From PACU admission to postoperative day 5
Postoperative hospital length of stay
Calculate the days from the date of surgery to the date of hospital discharge.
Time frame: From the day of surgery to the day of hospital discharge [within 1 month]