Effect of Lidocaine Through Gastric Tube on PONV
Effect of Lidocaine Applied Via Nasogastric Tube on Postoperative Nausea and Vomiting in Obese Patients Undergoing Bariatric Surgery
The goal of this clinical trial is to learn if intragastric administration of lidocaine can reduce postoperative nausea and vomiting in obese patients undergoing laparoscopic sleeve gastrectomy. The main question it aims to answer is:
Does administering 0.5% lidocaine via an orogastric tube reduce the incidence of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit and within the first 24 hours after surgery compared to a placebo (normal saline)?
Researchers will compare the Lidocaine Group to the Placebo Group to see if the intervention lowers the PONV incidence.
Participants will:
- Receive the assigned study solution (either 0.5% lidocaine 20ml or normal saline 20ml) through an orogastric tube upon surgery completion and before extubation.
- Have their gastric tube clamped for 5 minutes to ensure mucosal exposure before removal.
- Undergo standardized total intravenous anesthesia and perioperative management according to the study protocol.
- Be assessed for nausea, vomiting, and other outcomes at specified time points postoperatively in the recovery room and at 6, 12, and 24 hours.
調査の概要
詳細な説明
Postoperative nausea and vomiting (PONV) is a common complication following bariatric surgery, with incidence rates reaching up to 30-80%. In bariatric surgical patients, the burden of PONV is particularly high due to multiple risk factors, including surgical trauma to upper GI system, frequent opioid use, increased intra-abdominal pressure, altered gastric anatomy, and heightened sensitivity of gastrointestinal reflex pathways. Effective prevention and treatment of PONV in this population therefore represents a major clinical priority.
Current prophylactic strategies rely primarily on pharmacological agents such as serotonin (5-HT3) receptor antagonists, corticosteroids, dopamine antagonists, and multimodal combinations. Despite these measures, the incidence of breakthrough PONV remains significant, underscoring the need for additional safe, effective, and inexpensive interventions.
Lidocaine, traditionally used as a local anesthetic and antiarrhythmic, has gained attention in perioperative medicine for its systemic anti-inflammatory, analgesic, and opioid-sparing effects when administered intravenously. Evidence suggests that perioperative lidocaine can improve gastrointestinal motility, reduce visceral hypersensitivity, and facilitate earlier return of bowel function. These properties raise the possibility that lidocaine may also influence nausea and vomiting pathways by attenuating vagal afferent signaling, reducing local gastric irritation, and dampening inflammatory responses within the gastrointestinal mucosa.
Delivering lidocaine directly into the gastric cavity via an orogastric (OG) tube represents a novel and pragmatic approach. Unlike intravenous administration, intragastric instillation allows targeted mucosal exposure, potentially reducing afferent vagal stimulation that triggers nausea and vomiting. This method is technically simple, inexpensive, and feasible within the routine workflow of bariatric surgery, as OG tubes are already placed for intraoperative management.
This study aims to evaluate whether the administration of lidocaine via nasogastric tube can reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing bariatric surgery. If effective, local lidocaine administration may serve as a simple, low-cost, and readily adoptable strategy to improve postoperative outcomes in bariatric surgery patients. This approach could expand the multimodal anesthesia regimen and optimize the enhanced recovery after surgery (ERAS) pathway for bariatric procedures.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Siying He
- 電話番号：+86 18209610221
- メール：1342850868@qq.com
研究場所
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Ningxia
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Yinchuan、Ningxia、中国、750000
- 募集
- General Hospital of Ningxia Medical University
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コンタクト：
- General Hospital of Ningxia Medical University
- 電話番号：+86-0951-4091488
- メール：1342850868@qq.com
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-
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 between 18 and 65 years old;
- American Society of Anesthesiologists (ASA) physical status classification II - III;
- Planned to undergo primary elective laparoscopic sleeve gastrectomy with general anesthesia;
- Capable of giving informed consent.
Exclusion Criteria:
- Known allergy, hypersensitivity or contraindication to lidocaine or amide - type local anesthetics;
- Previous significant liver or kidney dysfunction (e.g., ALT/AST > 3 times the upper limit of normal, GFR < 30 mL/min);
- History of epilepsy, cardiac conduction abnormalities or previous diagnosis of malignant hyperthermia;
- Pregnancy or lactation;
- Patients who received systemic lidocaine treatment during the operation;
- History of severe postoperative nausea and vomiting (PONV) or motion sickness, requiring multiple prophylactic medications;
- Emergency or revision bariatric surgery.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Lidocaine
Lidocaine is administered via a gastric tube.
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Upon completion of the surgery and before extubation, 20 ml of 0.5% lidocaine should be administered through the pre - inserted orogastric tube.
The gastric tube should be clamped for 5 minutes to ensure sufficient mucosal exposure, and then removed before extubation.
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実験的：Normal Saline
Administer normal saline through the gastric tube.
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Before extubation after the surgery is completed, administer 20 ml of normal saline through the pre - inserted orogastric tube.
Clamp the gastric tube for 5 minutes to ensure sufficient mucosal exposure, and then remove the tube before extubation.
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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 |
時間枠 |
|---|---|
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The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.
時間枠：Within 24 hours after the operation
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Within 24 hours after the operation
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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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Degree of postoperative nausea and vomiting
時間枠：6 hours, 12 hours, and 24 hours after surgery
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The severity of nausea and vomiting was assessed using the Numerical Rating Scale at 6 hours, 12 hours, and 24 hours after surgery, respectively.
A score of 0 indicated no nausea or vomiting, and a score of 10 indicated the most severe nausea or vomiting.
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6 hours, 12 hours, and 24 hours after surgery
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Incidence rates of simple vomiting, simple nausea, and their combination during the postoperative anesthesia recovery room period and within 24 hours after surgery.
時間枠：Within 24 hours after the operation
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Within 24 hours after the operation
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Use rescue antiemetics
時間枠：Within 24 hours after surgery.
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Use of emergency antiemetic drugs and time nodes after surgery.
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Within 24 hours after surgery.
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Opioid use within 24 hours after surgery
時間枠：24 hours after surgery
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The amount of opioids used 24 hours after surgery.
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24 hours after surgery
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Time of first tolerable oral intake
時間枠：Within 72 hours after surgery.
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The time of the first oral tolerance to eating after surgery
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Within 72 hours after surgery.
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協力者と研究者
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
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。
PONVの臨床試験
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National Taiwan University Hospital完了血圧 | PONV | 心拍数 | バイスペクトル インデックス | Transcutaneous Carbon Dioxide台湾
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Qilu Pharmaceutical (Hainan) Co., Ltd.まだ募集していません
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Yonsei University完了
Lidocaineの臨床試験
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Allergan Medical完了
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BioplusAsan Medical Center; Seoul National University Hospital; Soonchunhyang University Hospital招待による登録