Anesthesia, General Clinical Trial
Official title:
The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study
Verified date | September 2023 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | August 11, 2023 |
Est. primary completion date | August 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Adult patients aged 19 years or older undergoing surgery under general anesthesia Exclusion Criteria: - Peripheral nerve block or Neuraxial block - Uncontrolled hypertension (HTN) (systolic blood pressure (SBP) =180 mmHg) - Uncontrolled diabetes mellitus (DM) (HbA1c =9.0%) - Hepatic dysfunction (Total bilirubin =3.0 mg/mL or Liver enzyme =Upper normal limit x 2.5) - Renal dysfunction (Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 or Dialysis) - Moderate or severe chronic obstructive pulmonary disease or Respiratory failure - Emergency - Hepatectomy or Liver transplantation - Intraoperative cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) use - Head trauma, Increased intracranial pressure, Craniotomy - Chronic use of benzodiazepines (BZDs) - Anxiety, Alcohol/Drug dependence, Addiction to tricyclic antidepressants (TCAs) - Allergic reaction to BZDs, flumazenil, or other drugs used in general anesthesia - Severe allergy or Anaphylaxis history - Lactose-related genetic disorders - Myasthenia gravis or Myasthenia gravis syndrome - Myocardial infarction or Cerebrovascular events within 6 months - Symptomatic coronary artery disease - Organic brain disease - Cognitive impairment (Inability to understand informed consent) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of emergence delirium | Richmond Agitation & Sedation Scale (RASS) =1 is considered emergence delirium. | From emergence to postanesthesia care unit (PACU) discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery] | |
Secondary | 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. | 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] | |
Secondary | Severity of POD | CAM-severity (CAM-S) is utilized to determine the severity of POD if it occurs. | From PACU to postoperative day 5 | |
Secondary | Duration of POD | 3D-CAM is utilized to check the duration of POD. | From PACU to postoperative day 5 | |
Secondary | Level of consciousness | Richmond Agitation & Sedation Scale (RASS) is used to evaluate the patients level of consciousness. | From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery | |
Secondary | Incidence of resedation | Richmond Agitation & Sedation Scale (RASS) =-2 is diagnosed as resedation. | From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery | |
Secondary | Time to eye-opening | Time taken for patients to open their eyes when their name is gently called after discontinuation of remimazolam. | After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation] | |
Secondary | Time to extubation | Time taken for patients to maintain spontaneous breathing and be extubated after remimazolam discontinuation. | After remimazolam cessation to extubation [within 30 min after remimazolam cessation] | |
Secondary | Preoperative anxiety | Amsterdam Preoperative Anxiety and Information Scale (APAIS) is used to evaluate the patient's anxiety before surgery | 1 day before surgery | |
Secondary | Postoperative nausea/vomiting (PONV) | Confirm PONV through patient's symptoms and signs. | From immediately after extubation to PACU discharge [within 2 hours after surgery] | |
Secondary | 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) | From PACU admission to postoperative day 5 | |
Secondary | Postoperative hospital length of stay | Calculate the days from the date of surgery to the date of hospital discharge. | From the day of surgery to the day of hospital discharge [within 1 month] |
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