【要旨】 われわれは本邦での歯科用局所麻酔剤アルチカイン塩酸塩・アドレナリン酒石酸水素塩注射剤（OKAD01）の第Ⅰ相試験を実施し，日本人でのアルチカインの薬物動態と安全性を明らかにした．そこで第Ⅰ相試験の結果に基づき，OKAD01の臨床用量域を，有効性および安全性の観点から検討するOKAD01の国内第Ⅱ相試験を実施した．

 歯科治療を受ける20～80歳の日本人成人患者を対象とした．予定された施術内容を用法に基づき，「歯科治療患者を対象とした浸潤麻酔」および「口腔外科患者を対象とした局所麻酔」に分類した．そのうえで，各用法を「施術の侵襲の程度（軽度，中等度，重度）」で分類した．各施術の侵襲の程度に応じた投与目安を設け，用量範囲でOKAD01を口腔内に単回投与した．主要評価項目は，Visual Analogue Scale（VAS）（0～10cm）を用いた患者による歯科施術中の痛みとした．

 治験薬を投与された55例（Safety Data Set：SDS）のうち，治験薬用法違反および適格基準違反の各1例を除いた53例（Full Analysis Set：FAS）における歯科施術中のVASの平均値（両側95%CI）は0.65（0.27～1.02）であった．また用法別では，「歯科治療患者を対象とした浸潤麻酔」（24例）で0.31（−0.04～0.67），「口腔外科患者を対象とした局所麻酔」（29例）で0.92（0.30～1.55）であった．またSDSにおいて因果関係が否定できない有害事象として「舌のしびれ」を1例認めた．

 本治験により本治験で規定および目安とした用法・用量で，日本人成人におけるOKAD01の有効性および安全性が確認された．

  Eosinophilic granulomatosis with polyangiitis (EGPA) is rare disease characterized by three phases : 1) a prodromic phase, 2) an eosinophilic phase, and 3) a vasculitic phase. Here, we report the anesthetic management for a patient with EGPA. The patient was a 47-year-old man (height, 165 cm ; weight, 75 kg) who had been diagnosed as having EGPA, hypertension, hyperlipidemia, hyperuricemia, type 2 diabetes, and osteoporosis. We scheduled wisdom teeth extraction surgery under general anesthesia because the position of the wisdom teeth was very close to the mandibular canal. To perform the anesthesia safely, we believed it necessary to evaluate the patient’s EGPA condition using the Five Factor Score. The evaluation revealed renal dysfunction, resulting in a Five Factor Score of 1. Therefore, we decided that it was possible to perform the anesthesia safely by preparing a β₂-stimulant (salbutamol sulfate) for use in case of an asthma attack. Anesthesia was induced with remifentanil (0.5 μg/kg/min) and propofol (130 mg) following preoxygenation. Mask ventilation was successfully achieved, and tracheal intubation was performed smoothly using a McGRATH^®. Because of the asthma risk, an expanded I : E ratio of 1 : 3 and a reduced tidal volume (0.6 mL/kg) were implemented as lung-protective ventilation strategies. In conclusion, for the safe anesthetic management of patients with EGPA, we think that an assessment using the Five Factor Score and preparation for an asthma attack are important.

  In the management of patients with cleft lip and palate necessitating orthognathic surgery to address jaw deformities after a pharyngeal flap procedure, challenges may arise during nasal intubation. These challenges can result in damage to the pharyngeal flap and hinder the placement of a tracheal tube. This report describes a case of 22-year-old man who was scheduled to undergo bilateral sagittal split ramus osteotomy following a pharyngeal flap procedure aimed at ameliorating nasopharyngeal obstruction dysfunction. Before planned surgery, an assessment conducted at our otorhinolaryngology clinic unveiled adhesions between the right inferior nasal turbinate and the nasal septum, rendering nasal intubation through the right nasal cavity unfeasible. Consequently, the patient underwent a two-step intubation procedure. First, oral intubation was performed to ensure airway maintenance, followed by the insertion of a nasotracheal tube through the left nasal cavity, guided by bronchoscopy, directing it towards the left-side pharyngeal flap orifice. If nasal intubation proved to be impracticable or effective respiratory management became difficult, the contingency plan entailed terminating the surgical procedure without resorting to submental endotracheal intubation or tracheostomy. Given the frequent involvement of dental anesthesiologists in cases where nasal intubation is required after pharyngeal flap surgery, it is of paramount importance to proactively mitigate the risk of pharyngeal flap damage. This involves a comprehensive preoperative assessment and simulation utilizing imaging and nasopharyngeal endoscopy, in addition to devising multiple intubation strategies and validation techniques for ascertaining the integrity of the pharyngeal flap based on established protocols and prior research findings.

 【要旨】 本稿では，全身麻酔中の周術期モニタリングの基礎とその落とし穴について詳細に解説した．麻酔科医が患者の状態を正確に評価するためには，モニタリング機器のみに依存せず，複数のパラメータを総合的に解釈することの重要性を強調した．また，個々の患者に合わせた麻酔管理が重要であり，モニタリング機器からの情報を細かく読み取り解釈することが，麻酔科医の技術向上のみならず，患者の安全に寄与することを述べた．