The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery
2026年6月3日 更新者：Yun Wu、The Second Hospital of Anhui Medical University
The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery: A Randomized Controlled Study
This study intends to conduct a prospective randomized controlled trial to implement esketamine-assisted anesthesia in patients undergoing open thyroidectomy, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.
調査の概要
研究の種類
介入
入学 (推定)
136
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yun Wu
- 電話番号：8613865958254
- メール：wuyunanyi@163.com
研究場所
-
-
Anhui
-
Hefei、Anhui、中国
- Second Affiliated hospital of Anhui Medical University
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patients scheduled for elective open thyroid surgery
- ASA class I-II
- Voluntarily participate in the study and sign the informed consent form
Exclusion Criteria:
- Body Mass Index > 30 kg/m²
- Patients with unstable ischemic cardiomyopathy, pulmonary hypertension, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure >180/100 mmHg)
- Hepatic or renal dysfunction
- History of oral, maxillofacial, neck, or airway surgery, or pathological structural alterations
- Respiratory diseases (COPD, asthma, inflammation, chronic cough)
- Patients with elevated intracranial pressure
- Patients undergoing repeat surgery
- History of allergy to the investigational drug used in the study
- Patients with psychiatric disorders or alcohol abuse (daily ethanol intake ≥40 g, or having experienced alcohol withdrawal within the past 6 months, or unable to control alcohol consumption)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ESK iv group
After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
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After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
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プラセボコンパレーター：CON group
After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;
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After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of coughing during tracheal extubation
時間枠：perioperative (From the awakening period to immediately after tracheal extubation)
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2 point scales; 0=None; 0 = Did not occur; 1 = Occurred;
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perioperative (From the awakening period to immediately after tracheal extubation)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Severity of coughing during tracheal extubation
時間枠：perioperative (From the awakening period to immediately after tracheal extubation)
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4 grade scales; Grade 0: No choking cough; Grade 1: Single cough episode, considered mild choking cough; Grade 2: Intermittent cough, lasting less than 5 seconds, considered moderate choking cough; Grade 3: Continuous severe cough, lasting more than 5 seconds, considered severe choking cough.
The higher the degree, the worse it is.
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perioperative (From the awakening period to immediately after tracheal extubation)
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Agitation score during tube removal
時間枠：perioperative (From the awakening period to immediately after tracheal extubation)
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3-level scale; 1: Awake and calm; 2: Mild agitation but can be comforted; 3: Moderate agitation, difficult to comfort; 4: Severe agitation, cannot be comforted; The higher the degree, the worse the situation.
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perioperative (From the awakening period to immediately after tracheal extubation)
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Blood pressure
時間枠：From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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From the induction period until 5 minutes after the completion of surgery
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Airway pressure 5 minutes after intubation and at the end of surgery
時間枠：5 minutes after intubation and at the end of the surgery
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5 minutes after intubation and at the end of the surgery
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Intraoperative use rate and dosage of vasoactive drugs
時間枠：intraoperative (From the induction period to the end of anesthesia)
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intraoperative (From the induction period to the end of anesthesia)
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Sore throat score
時間枠：Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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4-point scales; 0 = None; 1 = Mild, milder than a common cold; 2 = Moderate, like a sore throat from a common cold; 3 = Severe, more severe than a common cold; The higher the score, the greater the level of pain.
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Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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Hoarseness scores
時間枠：Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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4-point scores; 0 = None; 1 = Transient hoarseness occurs; 2 = Patient perceives hoarseness during visit; 3 = Hoarseness is clearly noticeable; The higher the score, the more severe the hoarseness.
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Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
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Surgical area pain scores
時間枠：Postoperative day 1 and day 2
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Pain NRS scale score: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain.
The higher the score, the more severe the pain.
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Postoperative day 1 and day 2
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Incidence of adverse reactions within 48 hours postoperatively
時間枠：Within day 2 after surgery
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Within day 2 after surgery
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Postoperative nausea and vomiting(PONV) score
時間枠：Within day 2 after surgery
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Vomiting: 0 = None; 1 = Once; 2 = Twice; 3 = Three times or more Nausea, does it affect daily life: 0 = None; 1 = Sometimes; 2 = Often; 3 = Always |
Within day 2 after surgery
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Postoperative analgesic dosage
時間枠：Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to first food
時間枠：perioperative (Time from returning to the ward to the first food)
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perioperative (Time from returning to the ward to the first food)
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Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
時間枠：Three month after surgery
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Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms
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Three month after surgery
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Heart rate
時間枠：Time Frame: From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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Time Frame: From the induction period until 5 minutes after the completion of surgery
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Oxygen saturation
時間枠：Time Frame: From the induction period until 5 minutes after the completion of surgery
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Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
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Time Frame: From the induction period until 5 minutes after the completion of surgery
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Anesthesia time
時間枠：perioperative (Time from induction to discontinuation of anesthetic agents)
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perioperative (Time from induction to discontinuation of anesthetic agents)
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Surgery time
時間枠：From the start of surgery to the end of surgery
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From the start of surgery to the end of surgery
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Extubation time
時間枠：perioperative (The time from discontinuation of anesthetic drugs to extubation)
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perioperative (The time from discontinuation of anesthetic drugs to extubation)
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Duration of tracheal tube placement
時間枠：perioperative (Time from intubation to )
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perioperative (Time from intubation to )
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Awakening time
時間枠：perioperative (Stop the anesthesia drug injection until awakening time)
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perioperative (Stop the anesthesia drug injection until awakening time)
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Post-anesthesia care unit (PACU) stay time
時間枠：perioperative (Duration from entering the PACU to leaving the PACU)
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perioperative (Duration from entering the PACU to leaving the PACU)
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PACU RASS score
時間枠：perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
|
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perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
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Intraoperative doses of propofol
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of remifentanil
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative doses of sufentanil
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative fluid volume
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative blood loss
時間枠：Intraoperative (From the induction period to the end of anesthesia)
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Intraoperative (From the induction period to the end of anesthesia)
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Sleep scores
時間枠：Postoperative 24 hours and 48 hours
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4 point scores; 1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.
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Postoperative 24 hours and 48 hours
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Antiemetic drug dosage
時間枠：Within day 2 after surgery
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Within day 2 after surgery
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Postoperative time to ambulation
時間枠：Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Length of postoperative hospital stay
時間枠：Perioperative (From the operating room to discharge)
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Perioperative (From the operating room to discharge)
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Postoperative time to first water intake
時間枠：Perioperative (Time from returning to the ward to the first drink of water)
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Perioperative (Time from returning to the ward to the first drink of water)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年5月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。