| 目的/Objectives |
| 目的1/Narrative objectives1 |
全身麻酔に際しては適切な麻酔深度を維持する必要があるが、ミダゾラムを用いた全身麻酔時の脳波についてはほとんど明らかになっていない。そこで、ミダゾラムを用いて麻酔導入を行った際の血中濃度と脳波の関係を明らかにし、より安全な麻酔方法の確立に努める。 |
Adequate anesthetic level is required during general anesthesia. Although midazolam is used for induction of general anesthesia, there is few information regarding the relationships between plasma concentration of midazolam and electroencephalogram. We investigate the relationships between the plasma concentration of midazolam and electroencephalogram. |
| 目的2/Basic objectives2 |
薬物動態・薬力学/PK,PD |
| 目的2 -その他詳細/Basic objectives -Others |
|
|
| 試験の性質1/Trial characteristics_1 |
|
| 試験の性質2/Trial characteristics_2 |
|
| 試験のフェーズ/Developmental phase |
|
| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
手術室において脳波の記録を開始した後、ミダゾラム0.2 mg/kgの単回静脈投与で麻酔を導入、気管挿管を行う。ミダゾラムの投与5,10,15,20,30,45,60分後に動脈または静脈内に留置したカテーテルから採血を行う。この後手術を開始する。 |
After starting recoriding of electroencephalogram in the operating room, general anesthesia is induced with bolus midazolam of 0.2 mg/kg and the trachea is intubated. Blood is obtained from indwelling arterial or venous catheters 5, 10, 15, 20, 30, 45 and 60 minutes following induction of anesthesia.
|
| 介入2/Interventions/Control_2 |
手術室において脳波の記録を開始した後、ミダゾラム0.3 mg/kgの単回静脈投与で麻酔を導入、気管挿管を行う。ミダゾラムの投与5,10,15,20,30,45,60分後に動脈または静脈内に留置したカテーテルから採血を行う。この後手術を開始する。 |
After starting recoriding of electroencephalogram in the operating room, general anesthesia is induced with bolus midazolam of 0.3 mg/kg and the trachea is intubated. Blood is obtained from indwelling arterial or venous catheters 5, 10, 15, 20, 30, 45 and 60 minutes following induction of anesthesia. |
| 介入3/Interventions/Control_3 |
|
|
| 介入4/Interventions/Control_4 |
|
|
| 介入5/Interventions/Control_5 |
|
|
| 介入6/Interventions/Control_6 |
|
|
| 介入7/Interventions/Control_7 |
|
|
| 介入8/Interventions/Control_8 |
|
|
| 介入9/Interventions/Control_9 |
|
|
| 介入10/Interventions/Control_10 |
|
|
| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
|
| 年齢（上限）/Age-upper limit |
|
| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
気管挿管による全身麻酔下で体表、四肢の手術を予定された70歳以下の症例 |
Patients undergoing operations of body surface or extremities under general anesthesia |
| 除外基準/Key exclusion criteria |
1) 開胸・開腹手術を受ける症例、2) 高度の肝機能、腎機能障害を伴う場合、3) 術前にミダゾラムの代謝酵素であるチトクロームP4503A (CYP3A)の誘導薬や阻害薬を服用している場合、4) 極度の肥満などで気管挿管の困難が予測される場合、5) 麻酔中にCYP3A阻害薬の投与を行った場合、6) 脳波に影響を及ぼす可能性のある薬物を常用している場合 |
1) patients undergoing thoracotomy or lapalotomy, 2) patients with advanced hepatic or renal dysfunction, 3) taking cytochrome P4503A inducers or inhibitors preoperatively, 4) predicted difficulty in tracheal intubation, 5) receiving CYP3A inhibitors during anesthesia, 6) receiving medications affecting electroencephalogram |
| 目標参加者数/Target sample size |
30 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
|
| 組み入れ参加者数/Number of participants that the trial has enrolled |
|
| 主な結果/Results |
ミダゾラム0.2mgおよび0.3mgの静脈投与による麻酔導入で、ミダゾラムの薬物動態においては最高血中濃度のみに相違が認められた。ミダゾラムの血中濃度および効果部位の予想濃度とも急速に低下したが、何れも0.3mg群が0.2mg群に比べて高かった。脳波の変化殆ど無く、Bispectral Index (BIS)も両群間で差は無かった。 |
Plasma and simulated effect site concentrations of midazolam decreased rapidly and were significantly higher in the large-dose group than in the small-dose group (P = 0.005 and < 0.001, respectively). Both BIS and relative beta ratio decreased after induction and remained between 60 and 70, between -1.8 and -1.2, respectively. No differences were observed in BIS, relative beta ratio or 95% spectral edge frequency between the two groups, either. Relative beta ratio significantly correlated with BIS in both groups (r2 = 0.66 and 0.78, respectively, P < 0.001 for both). The electroencephalographic spectral power density in the beta- (≥13 and <30 Hz) band was significantly increased after induction, besides being significantly larger in the large-dose group than in the small-dose group (P = 0.009). |
| 主な結果入力日/Results date posted |
|
| 結果掲載遅延/Results Delayed |
|
| 結果遅延理由/Results Delay Reason |
|
|
| 最初の試験結果の出版日/Date of the first journal publication of results |
|
| 参加者背景/Baseline Characteristics |
|
|
| 参加者の流れ/Participant flow |
|
|
| 有害事象/Adverse events |
|
|
| 評価項目/Outcome measures |
|
|
| 個別症例データ共有計画/Plan to share IPD |
|
|
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
|
|
UMIN-CTR ホーム