ENDOTRACHEAL Tube LIDOCAINE (ETT LIDOCAINE)
Application of a 5% Lidocaine Ointment to Endotracheal Tubes to Reduce Emergence Bucking: a Randomized Double-Blind Prospective Trial.
調査の概要
詳細な説明
Emergence coughing or bucking is a common complication of general anesthesia with endotracheal intubation and may result in clinically significant increases in hemodynamic stress, airway irritation, postoperative discomfort, and potential complications. Although multiple pharmacologic strategies have been evaluated to reduce emergence coughing, the effectiveness of topical lidocaine preparations applied to the endotracheal tube remains uncertain.
This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to the external surface of the endotracheal tube before intubation reduces coughing or bucking during emergence from general anesthesia compared with standard water-based endotracheal tube lubricant.
Adult patients undergoing elective surgical procedures requiring general anesthesia with oral endotracheal intubation will be randomized to receive either 5% lidocaine ointment or standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to intubation. The study will use standardized anesthetic management, double-blinding procedures, and consistent outcome assessment methods.
The primary outcome is the incidence of coughing or bucking during emergence from anesthesia, assessed from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. Secondary outcomes include the incidence and severity of postoperative sore throat and hoarseness at defined postoperative time points, as well as total intraoperative opioid administration converted to morphine milligram equivalents.
Additional demographic and procedural information, including age, sex, body mass index, American Society of Anesthesiologists physical status, airway assessment characteristics, duration of intubation, and surgical procedure type, will be collected to describe the study population and evaluate potential factors associated with outcomes.
The study aims to determine whether 5% lidocaine ointment provides a clinically useful strategy for reducing emergence-related airway irritation and improving postoperative airway comfort compared with standard endotracheal tube lubrication.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Ling-Qun Hu, MD
- 電話番号：6142933559
- メール：lingqun.hu@osumc.edu
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43201
- 募集
- The Ohio State University Wexner Medical Center
-
コンタクト：
- Ling-Qun Hu
-
コンタクト：
- Ling-Qun Hu, MD
- 電話番号：614-293-3559
- メール：lingqun.hu@osumc.edu
-
-
参加基準
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
説明
Inclusion Criteria:
Adults aged 18 years and older, with an upper age limit of 90 years, scheduled for surgery requiring general anesthesia with an oral endotracheal tube.
Patients undergoing general surgical procedures, including but not limited to abdominal surgeries (e.g., hernia repairs, cholecystectomy, appendectomy, bowel surgery), non-cervical spinal surgeries, craniotomies, orthopedic procedures, urologic procedures, and other procedures meeting the inclusion criteria.
American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV. Patients able to provide informed consent.
Exclusion Criteria:
Age younger than 18 years or older than 90 years. Patients undergoing procedures requiring a specialized airway device instead of a standard oral endotracheal tube (e.g., laryngeal mask airway, double-lumen endobronchial tube).
Patients with known hypersensitivity or allergy to amide local anesthetics. Patients with pre-existing sore throat, upper respiratory infection, or active cough at baseline.
Patients requiring postoperative mechanical ventilation or critically ill patients requiring intensive care.
Patients unable to adequately report outcomes or participate in follow-up assessments.
Current smokers. Pregnant women. Prisoners.
研究計画
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：5% Lidocaine Ointment
Participants randomized to this arm will receive 5% lidocaine ointment applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation.
The ointment will be applied according to the study protocol before induction of general anesthesia.
|
A 5% lidocaine ointment will be applied as a thin, uniform layer to the external surface of the endotracheal tube immediately before endotracheal intubation.
The ointment will be applied once according to the study protocol before induction of general anesthesia.
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アクティブコンパレータ：Water-Based Lubricant
Participants randomized to this arm will receive the institution's standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation. The lubricant will be applied according to routine clinical practice before induction of general anesthesia. These entries are appropriate because both treatments are established clinical practices, with the investigational intervention being compared against an active standard-of-care comparator. |
Institutional standard water-based endotracheal tube lubricant will be applied to the external surface of the endotracheal tube immediately before endotracheal intubation according to routine clinical practice before induction of general anesthesia.
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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 or Bucking During Emergence from General Anesthesia
時間枠：From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).
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The incidence of coughing or bucking occurring during emergence from anesthesia, defined as any cough or bucking movement from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube.
The outcome will be assessed by direct observation and recorded as the presence or absence of coughing/bucking and the number of bucking episodes using a standardized assessment.
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From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).
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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 |
|---|---|---|
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Incidence and Severity of Postoperative Sore Throat
時間枠：2 hours and 24 (±3) hours after extubation.
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Incidence and severity of postoperative sore throat will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Moderate or severe sore throat will be considered clinically significant for analysis.
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2 hours and 24 (±3) hours after extubation.
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Incidence and Severity of Postoperative Hoarseness
時間枠：2 hours and 24 (±3) hours after extubation.
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Incidence and severity of postoperative hoarseness will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Moderate or severe hoarseness will be considered clinically significant for analysis.
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2 hours and 24 (±3) hours after extubation.
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Total Intraoperative Opioid Use
時間枠：From induction of anesthesia until endotracheal tube removal during the intraoperative period.
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Total opioid administration from induction of anesthesia until extubation, converted to morphine milligram equivalents (MME) for analysis.
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From induction of anesthesia until endotracheal tube removal during the intraoperative period.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY20260673
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