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midazolam (ITI 111 / USL 261 / ITI111)

✓ Approved

Ikano Therapeutics · GABRA1 · 小分子

什么是 midazolam？

midazolam 是一种小分子，由Ikano Therapeutics研发。该药已获批，用于治疗相关适应症，给药途径：Inhaled、Intranasal。

药物档案

商品名ITI 111, USL 261, ITI111
公司Ikano Therapeutics
药物类别小分子
分子靶点GABRA1, GABRA2, GABRA3, GABRA4, GABRA5
给药途径Inhaled, Intranasal
状态Approved
来源： ClinicalTrials.gov, Ikano Therapeutics

作用机制

分子靶点

midazolam 作用于 5 个分子靶点：

GABRA1gamma-aminobutyric acid type A receptor alpha1 subunit (DEE19, ECA4)
GABRA2gamma-aminobutyric acid type A receptor alpha2 subunit (DEE78, EIEE78)
GABRA3gamma-aminobutyric acid type A receptor alpha3 subunit (EPILX2)
GABRA4gamma-aminobutyric acid type A receptor alpha4 subunit ()
GABRA5gamma-aminobutyric acid type A receptor alpha5 subunit (EIEE79, DEE79)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

midazolam 针对 7 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Nervous system disordersPartial seizuresPhase III
Nervous system disordersEpilepsyPhase III
Nervous system disordersIdiopathic generalised epilepsyPhase III
Nervous system disordersAmnesiaPhase I
Nervous system disordersAnaesthesiaPhase I

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相关研究文献

PubMedPacing and clinical electrophysiology : PACE2026-10-26

The Effectiveness and Safety of Deep Sedation Protocols for Pulsed Field Ablation of Atrial Fibrillation.

Zhao Yize Y, Li Fadong F, Wang Jue J, Zhou Le L et al.

Deep sedation (DS) is increasingly utilized during pulsed field ablation (PFA) for atrial fibrillation (AF), but the optimal electrophysiologist-led sedation regimen remains unclear. To compare sedative effectiveness and safety of three electrophysiologist-led DS protocols. In this prospective, single-center study, AF patients undergoing focal-form PFA received (1) midazolam + fentanyl (Midazolam group), (2) flurbiprofen axetil + midazolam + fentanyl (Flurbiprofen group), or (3) dexmedetomidine + fentanyl (Dexmedetomidine group). The primary endpoint was the achievement of the target sedation level at ablation initiation (Ramsay Sedation Score ≥3). Secondary endpoints included intraoperative pain, sedation difficulty, operator satisfaction, and sedation-related adverse events. 166 patients (mean age, 62.2 ± 10.8 years; 62.7% male; 48.2% with paroxysmal AF) were enrolled, with 53, 67, and 46 patients included in the Midazolam, Flurbiprofen, and Dexmedetomidine groups, respectively. The primary outcome occurred more frequently in the Flurbiprofen (73.1%) and Dexmedetomidine (82.6%) groups compared to Midazolam (47.2%) (overall p < 0.001); Flurbiprofen and Dexmedetomidine group did not differ significantly. Intraoperative pain scores were lowest with Dexmedetomidine (overall p < 0.001). Both Flurbiprofen and Dexmedetomidine groups showed lower sedation difficulty and higher operator satisfaction than the Midazolam group (both overall p < 0.001). Dexmedetomidine was associated with more intraoperative hypotension (overall p = 0.047). Electrophysiologist-led DS protocols with Flurbiprofen and Dexmedetomidine were associated with higher target sedation attainment than the specific low-dose Midazolam regimen during PFA, but Dexmedetomidine is linked to higher hypotension rates, warranting caution.

PMID 42929317
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PubMedPacing and clinical electrophysiology : PACE2026-10-26

Sedation Versus General Anesthesia During Pediatric Electrophysiology Studies: A Paired Comparison.

Kucuker Hakan H, Genc Abdusselam A, Akesen Selcan S, Turkmen Hasan H et al.

Anesthetic strategy may influence tachycardia inducibility during pediatric electrophysiology studies, but direct paired comparisons between sedation and general anesthesia remain limited. This prospective paired-comparison study included 51 pediatric patients aged 5-21 years with supraventricular tachycardia undergoing electrophysiology study under both procedural sedation and general anesthesia during the same session. Procedural sedation consisted of midazolam, fentanyl, and supplemental propofol boluses as needed. General anesthesia was induced with propofol and fentanyl and maintained with sevoflurane. Tachycardia inducibility and electrophysiological parameters were compared between anesthetic conditions using paired analyses. Overall tachycardia inducibility was higher during sedation than during general anesthesia (40/51 [78.4%] vs. 29/51 [56.9%], p = 0.007). No significant differences were observed in atrial effective refractory period, ventricular effective refractory period, atrioventricular nodal Wenckebach point, jump, echo interval, or ventriculoatrial block duration. In patients with atrioventricular nodal reentrant tachycardia, inducibility decreased from 84.0% during sedation to 60.0% during general anesthesia (p = 0.109). In the Wolff-Parkinson-White/atrioventricular reentrant tachycardia subgroup, inducibility decreased from 73.1% to 53.8% (p = 0.063), and the accessory pathway effective refractory period, measured by extrastimulus pacing, was prolonged under general anesthesia (p = 0.018). Procedural sedation was associated with greater overall tachycardia inducibility than general anesthesia during pediatric electrophysiology studies. The AVNRT and WPW/AVRT subgroups showed numerically lower inducibility under general anesthesia in the same direction as the overall finding, although these subgroup differences did not reach statistical significance. These findings support individualized anesthetic planning that considers the arrhythmia substrate, the need to preserve inducibility for mapping and post-ablation validation, and patient-specific requirements for procedural stability.

PMID 42929424
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PubMedEuropean journal of dental education : official journal of the Association for Dental Education in Europe2026-10-26

Assessment of Preparedness for Medical Emergencies in Saudi Dental Colleges: A National Cross-Sectional Study.

El-Haddad Sally Abd El-Meniem SAE

Medical emergencies can occur during dental treatment and may become life-threatening without timely and appropriate management. Dental colleges have a dual responsibility to ensure patient safety in their clinical facilities and to prepare future dentists to recognise and manage medical emergencies. However, national-level evidence regarding emergency preparedness across dental colleges in Saudi Arabia remains limited. To assess medical emergency preparedness among dental colleges in Saudi Arabia by evaluating personnel preparedness; the availability of essential emergency equipment and medications; medication storage and safety practices; and institutional self-perceived preparedness, and to explore differences between governmental and private dental colleges. A national cross-sectional institutional survey was conducted using a census approach. All 28 dental colleges identified in Saudi Arabia in 2025 were invited to participate, including 20 governmental and 8 private colleges. Data were collected using a structured, pilot-tested institutional questionnaire covering personnel preparedness; emergency equipment and medications; storage and safety practices; and institutional self-perceived preparedness. Categorical data were summarised using frequencies and percentages. Exploratory comparisons between governmental and private colleges were performed using two-sided Fisher's exact tests. Because 46 item-level comparisons were conducted, Holm adjustment was applied as a sensitivity analysis for multiple comparisons. Completed questionnaires were received from 26 colleges (18 governmental and 8 private), yielding an overall response rate of 92.9%. Among the 26 participating colleges, 16 (61.5%) reported incorporating medical emergency-management courses into their curricula, while 10 (38.5%) conducted periodic mock emergency drills. Annual basic life support (BLS) training for newly joined staff and annual BLS renewal were each reported by 17 colleges (65.4%). Staff access to emergency drugs and equipment was reported by 19 colleges (73.1%), whereas only 9 (34.6%) reported that students and staff knew how to use dental emergency medications. Emergency kits/carts and automated external defibrillators (AEDs) were each available in 24 dental colleges (92.3%), while sphygmomanometers were available in 25 (96.2%). Availability was lower for Magill forceps (38.5%) and nebulizers (30.8%). Oral glucose was available in 25 dental colleges (96.2%), whereas glucagon (26.9%), aminophylline (19.2%) and intranasal/buccal midazolam (11.5%) were less frequently available. Baseline vital-sign recording was mandated in 8 colleges (30.8%), despite patient history being mandated in 25 (96.2%). Regarding institutional self-perceived preparedness, none of the participating dental colleges rated their preparedness as "very well" prepared. 20 (76.9%) rated themselves as "fairly well" prepared, and 6 (23.1%) reported "limited" preparedness. Several nominal differences were observed between dental governmental and private colleges in individual preparedness indicators; however, none remained statistically significant after Holm correction. Medical emergency preparedness among Saudi dental colleges appears adequate in several fundamental preparedness domains but remains variable, particularly regarding practical training, simulation drills, selected emergency equipment and medications and routine baseline vital-sign assessment. These findings support the development of standardised national preparedness benchmarks, regular simulation-based training and systematic monitoring of emergency equipment and medication readiness across dental colleges.

PMID 42928625
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PubMedJournal of cardiothoracic and vascular anesthesia2026-10-23

Association of Enteral Chloral Hydrate with Benzodiazepine Exposure and Delirium After Pediatric Cardiac Surgery: A Retrospective Before-and-After Cohort Study.

Ozden Omer O, Yakici Aslı Ece AE, Isik Elif E, Kabadayi Berk B et al.

To evaluate the association between the addition of enteral chloral hydrate to a postoperative sedation protocol and benzodiazepine exposure, sedation quality, withdrawal, delirium, and short-term clinical outcomes in children undergoing congenital heart surgery. Single-center retrospective before-and-after cohort study. Pediatric cardiac intensive care unit of a tertiary referral center. Eighty-six children who underwent congenital heart surgery with cardiopulmonary bypass, required postoperative mechanical ventilation for more than 24 hours, and received sedation for at least 24 hours. Patients were treated according to the institutional postoperative sedation protocol before (July 2021-June 2023) and after (August 2023-July 2025) implementation of enteral chloral hydrate as an adjunctive sedative. The primary endpoint was cumulative midazolam exposure during the pediatric cardiac intensive care unit stay. Secondary endpoints included sedative and analgesic requirements, sedation and pain scores, withdrawal, delirium, and clinical outcomes. Compared with the preprotocol group, the chloral hydrate group had significantly lower cumulative midazolam exposure (10.2 v 13.2 mg/kg, p = 0.010) and peak midazolam infusion rates (0.15 v 0.20 mg/kg/h, p < 0.001), and a lower observed frequency of delirium (14.6% v 37.8%, p = 0.015). No significant between-group differences were observed in sedation quality, pain scores, withdrawal, duration of mechanical ventilation, length of stay in the pediatric cardiac intensive care unit or hospital, or mortality. Addition of enteral chloral hydrate to a postoperative sedation protocol was associated with reduced benzodiazepine exposure and a lower observed frequency of delirium without statistically significant differences in sedation quality or short-term clinical outcomes. Prospective multicenter studies are warranted to confirm these findings.

PMID 42919780
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PubMedCase reports in anesthesiology2026-10-23

Anesthesia Considerations for Transfemoral Osseointegration in a Patient With CRPS, Propofol, and Ketamine Allergies: A Case Report.

Fanizza Jake D JD, Hoellwarth Jason Shih JS, Umeh Uchenna O UO

A 20-year-old female with asthma, Ehlers-Danlos syndrome, Hashimoto's thyroiditis, mast cell activation syndrome, and complex regional pain syndrome Type 1 (CRPS1) presented for left transfemoral amputation with osseointegration and nerve reconstruction. To limit CRPS1 exacerbation, neuraxial anesthesia with femoral and sciatic blocks was administered for analgesia. Given the reported history of convulsions following ketamine and propofol, sedation with midazolam, dexmedetomidine, and fentanyl was used. On POD 1, fascia iliaca and sciatic blocks were repeated to mitigate postoperative pain. There were no intraoperative or postoperative complications. With limited literature on anesthesia for osseointegration, this novel case highlights individualized planning, in the setting of adverse responses to anesthetic medications and challenging pain management.

PMID 42909998
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PubMedFrontiers in artificial intelligence2026-10-22

Early midazolam exposure and short-term risk of acute exacerbation of COPD in critically ill patients: a target trial emulation using the MIMIC-IV database.

Qin Guoping G, Zou Kun K

Sedation is frequently required in the intensive care unit (ICU), but benzodiazepines may worsen respiratory outcomes in patients with chronic obstructive pulmonary disease (COPD). To evaluate whether early midazolam exposure after ICU admission is associated with the short-term risk of acute exacerbation of COPD (AECOPD) among critically ill COPD patients. Using the Medical Information Mart for Intensive Care IV (MIMIC-IV) database, we emulated a target trial and applied a clone-censor-weight (CCW) approach to address immortal time bias and informative censoring. Exposure was midazolam administration within a grace period after ICU admission (primary: 24 h; sensitivity: 12 and 36 h). The primary outcome was AECOPD, defined as initiation of systemic corticosteroids or antibiotics between 24 h and 7 days after ICU admission. Outcomes were compared using inverse probability of censoring weights (IPCW). Among 3,416 ICU stays, 233 (6.8%) received midazolam within 24 h. After IPCW weighting, AECOPD incidence was 29.8% in the midazolam group versus 23.5% in controls (risk difference +6.3%, 95% CI -2.7% to +15.8%; odds ratio 1.38, 95% CI 0.86-2.12; p = 0.158). Findings were directionally consistent across grace periods (12 h OR 1.64; 36 h OR 1.29), but none of the grace-period comparisons reached statistical significance. In the primary 24 h analysis, early midazolam exposure was associated with a numerically higher short-term AECOPD risk. These observational findings cannot establish causality, and the present study did not demonstrate a statistically significant causal effect; nevertheless, in view of existing ICU sedation evidence, continued caution in the use of midazolam in critically ill COPD patients appears prudent.

PMID 42903200
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