| 目的/Objectives |
| 目的1/Narrative objectives1 |
不安と抑鬱の評価をする日本版 HADSを術前に評価し、PONV の発生とPONVに関与する因子検証を加え、高精度なPONV 予測モデルの作成において、日本版HADSが有用な要因になりうる事を探索的に検討すること。 |
The Japanese version of HADS, which evaluates anxiety and depression, can be a useful factor in creating a highly accurate PONV prediction model by preoperatively evaluating the occurrence of PONV and verifying factors involved in PONV. Consider things exploratory. |
| 目的2/Basic objectives2 |
その他/Others |
| 目的2 -その他詳細/Basic objectives -Others |
日本版HADSを含めた予測モデルと既存の予測モデルを比較して、精度の高いモデルが作成できるか検証すること。 |
Compare the predictive model including the Japanese version of HADS with the existing predictive model to verify whether a highly accurate model can be created. |
| 試験の性質1/Trial characteristics_1 |
探索的/Exploratory |
| 試験の性質2/Trial characteristics_2 |
実務的/Pragmatic |
| 試験のフェーズ/Developmental phase |
該当せず/Not applicable |
| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
術前に評価した日本版HADSが術後PONV悪心嘔吐の発生要因となるかを調べる。 |
To investigate whether the Japanese version of HADS evaluated before surgery causes postoperative PONV nausea and vomiting. |
| 副次アウトカム評価項目/Key secondary outcomes |
患者情報：年齢、性別、既往歴、身長、体重、飲酒、喫煙、PONV 既往、不眠
手術情報：手術術式、手術時間、麻酔時間、出血量、補液量、術中麻薬使用量、術中BIS ( Bispectral Index )
術後情報：オピオイド使用量、疼痛 ( NRS : Numerical Rating Scale ) 、せん妄 ( CAM-ICU )、metoclopramide の使用回数 |
Patient information: age, gender, medical history, height, weight, drinking, smoking, PONV medical history, insomnia
Surgical information: Surgical procedure, surgical time, anesthesia time, bleeding volume, fluid replacement volume, intraoperative drug usage, intraoperative BIS (Bispectral Index)
Postoperative information: Opioid use, pain (NRS: Numerical Rating Scale), delirium (CAM-ICU), number of times metoclopramide is used |
| 介入/Intervention |
| 群数/No. of arms |
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| 介入の目的/Purpose of intervention |
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| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
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| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
・呼吸器外科で胸腔鏡手術が予定されている患者
・登録時年齢が 20 歳以上 ( 上限なし ) の患者
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Patients scheduled for thoracoscopic surgery in respiratory surgery
Patients aged 20 years or older (no upper limit) at the time of enrollment |
| 除外基準/Key exclusion criteria |
・日本語を理解できない患者
・緊急手術の患者
・基礎疾患により、術前よりめまいや悪心嘔吐症状を有する患者
・局所麻酔薬に対するアレルギーを有する患者
・胸部再手術の患者
・術中所見により開胸手術に移行した患者
・術前より向精神薬を内服中の患者
・その他、本研究担当医師が対象として不適切と判断した患者 |
Patients who do not understand Japanese
Patients with emergency surgery
Patients with dizziness or nausea and vomiting due to underlying disease
Patients with allergies to local anesthetics
Patients with chest reoperation
Patients who have undergone thoracotomy due to intraoperative findings
Patients taking psychotropic drugs before surgery
Other patients who are judged to be inappropriate by the doctor in charge of this research |
| 目標参加者数/Target sample size |
100 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
Information other than the content described on this site is not open to the public |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
98 |
| 主な結果/Results |
PONVの発生は22例(22.4%)であった。PONVあり群とPONVなし群で比較すると、Anxiety scoreは4.0(2.0-7.0) vs 6.5(4.0-9.8)、Depression scoreは4.0(2.0-8.0) vs 6.0(2.5-8.0)であった。(median (quartiles: Q1‐Q3)) |
The incidence of PONV was 22 (22.4%). Comparing the group with PONV and the group without PONV, the Anxiety score was 4.0 (2.0-7.0) vs 6.5 (4.0-9.8) and the Depression score was 4.0 (2.0-8.0) vs 6.0 (2.5-8.0). (median (quartiles: Q1-Q3)) |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
男性63例、女性35例。年齢は72(66.3-76.0)歳、身長は160.2(155.3-166.2)cm、体重は59.2(53.1-63.4)kg、喫煙者は62名であった。PONV既往は7例、不眠は39例で認めた。(median (quartiles: Q1‐Q3)) |
63 males and 35 females. The age was 72 (66.3-76.0) years, the height was 160.2 (155.3-166.2) cm, the weight was 59.2 (53.1-63.4) kg, and there were 62 smokers. A history of PONV was observed in 7 cases, and insomnia was observed in 39 cases. (median (quartiles: Q1-Q3)) |
| 参加者の流れ/Participant flow |
術前外来の看護師が、日本版 HADS を用いたアンケート調査を実施した。術前の外来でアンケート結果は、担当麻酔医、患者本人、担当看護師には知らされておらず、手術後72時間までは封筒にいれて封緘され、だれも結果を見られないようにしたため、担当麻酔医および術後回診麻酔や手術麻酔看護師、病棟看護師は盲検化された。不眠については、手術当日の朝に問診し、自己申告により不眠ありと不眠なしに分類した。 |
A preoperative outpatient nurse conducted a questionnaire survey using the Japanese version of HADS. The results of the questionnaire in the preoperative outpatient department were not known to the anesthesia doctor in charge, the patient himself, or the nurse in charge, and were sealed in an envelope until 72 hours after the operation so that no one could see the results. The anesthesia doctor in charge and the postoperative round anesthesia and surgical anesthesia nurses, and the ward nurses were blinded. Insomnia was interviewed on the morning of the day of surgery, and self-reported and classified into insomnia and no insomnia. |
| 有害事象/Adverse events |
なし |
None |
| 評価項目/Outcome measures |
22例(22.4%)でPONVが発生した。Anxiety scoreは4.5(2.0-7.8)点、Depression scoreは5.0(2.0-8.0)点であった。術中fentanyl使用量は6.3(4.9-7.4)mcg/kg、術後にfentanylを必要とした症例は7例だった。手術時間は125(85.5-147.5)分、術中補液量は17.6(13.2-22.8)mL/kgだった。(median (quartiles: Q1‐Q3)) |
PONV occurred in 22 cases (22.4%). The Anxiety score was 4.5 (2.0-7.8) points and the Depression score was 5.0 (2.0-8.0) points. The intraoperative fentanyl usage was 6.3 (4.9-7.4) mcg / kg, and 7 cases required postoperative fentanyl. The operation time was 125 (85.5-147.5) minutes, and the intraoperative replenishment volume was 17.6 (13.2-22.8) mL / kg. (median (quartiles: Q1-Q3)) |
| 個別症例データ共有計画/Plan to share IPD |
なし |
None |
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
なし |
None |
UMIN-CTR 臨床試験登録情報の閲覧