Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.
Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection: a Randomized Controlled Trial.
This is a prospective, single-center, randomized, double-blind controlled trial involving patients scheduled for elective surgery requiring general anesthesia with propofol induction. Participants are randomly assigned to one of three groups: the ondansetron group (8 mg IV), the lidocaine group (40 mg IV), or the control group (0.9% normal saline placebo). Study medications are administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
the goal: To assess the efficacy of intravenous ondansetron versus lidocaine and placebo in reducing the incidence and intensity of pain associated with propofol injection in patients undergoing general anesthesia.
調査の概要
状態
詳細な説明
This prospective, single-center, randomized, double-blind controlled trial is conducted at the operating theaters of the Mongi Slim University Hospital (Tunisia). The study aime to compare the effectiveness of intravenous ondansetron and lidocaine versus placebo in preventing pain associated with propofol injection during induction of general anesthesia.
Adult patients (ASA I-III) scheduled for elective surgery requiring propofol-based induction are randomly allocated in a 1:1:1 ratio to receive either ondansetron 8 mg, lidocaine 40 mg, or normal saline placebo before anesthesia induction. The primary outcome is the incidence of pain during propofol injection, while secondary outcomes include pain intensity, postoperative nausea and vomiting, patient satisfaction, and pain recall.
A total of 156 patients are planned for inclusion. Pain is assessed immediately after administration of an initial propofol bolus using a numerical rating scale (0-10) by a blinded observer. The study is designed to determine whether ondansetron could provide analgesic efficacy comparable to the current standard treatment, lidocaine, while also offering potential benefits related to the prevention of postoperative nausea and vomiting.
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：Mhamed Sami Mebazaa, professor
- 電話番号：00216 22252589
- メール：msmebazaa@gmail.com
研究連絡先のバックアップ
- 名前：Amani Ben Haj youssef, assistant
- 電話番号：00216 96874336
- メール：amani.benhajyoussef@fmt.utm.tn
研究場所
-
-
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Tunis、チュニジア、2046
- Mongi Slim Hospital
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コンタクト：
- Amani Ben Haj youssef
- 電話番号：96874336
- メール：amani.benhajyoussef@fmt.utm.tn
-
コンタクト：
-
主任研究者：
- Amani Ben Haj youssef, Assistant
-
-
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:
- The study included patients who met all of the following criteria:
Aged 18 years or older; Classified as ASA physical status I-III (Appendix 1); Provided written informed consent to participate in the study; Scheduled for elective surgery requiring general anesthesia with propofol induction.
Exclusion Criteria:
- Patients were not eligible for inclusion if they:
Had received analgesics or antiemetics within 12 hours before surgery; Had communication difficulties or were unable to assess pain adequately (e.g., language barrier, dementia, impaired consciousness); Had a known allergy to ondansetron, lidocaine, or propofol; Did not receive propofol for anesthetic induction; Were pregnant or breastfeeding; Suffered from chronic pain or regularly used opioid medications; Did not have a 20-gauge intravenous catheter inserted on the dorsum of the hand; Declined participation in the study.
Patients were excluded from the study if they experienced any complication during anesthetic induction, including:
Anaphylactic shock or allergic reaction to study medications; Hemodynamic or respiratory instability.
Patients who subsequently withdrew their consent were also excluded from the study.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Group C (Control):
Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline
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Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline (placebo) administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
|
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実験的：Group O (Ondansetron)
Group O (Ondansetron): Patients receive 8 mg of ondansetron
|
Patients received 8 mg of ondansetron diluted to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
|
|
アクティブコンパレータ：Group L (Lidocaine)
Group L (Lidocaine): Patients received 40 mg of lidocaine
|
Patients received 40 mg of lidocaine diluted with 0.9% normal saline to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
|
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 |
|---|---|
|
Incidence of pain during propofol injection
時間枠：During induction of general anesthesia
|
During induction of general anesthesia
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intensity of pain during propofol injection
時間枠：during the induction
|
Intensity of pain during propofol injection, assessed using a Numerical Rating Scale (NRS) from 0 to 10: 0: No pain 1-3: Mild pain, or pain reported only in response to questioning 4-6: Moderate pain, or pain reported spontaneously without facial grimacing 7-10: Severe pain, characterized by marked vocal expression, facial grimacing, arm withdrawal, or tears |
during the induction
|
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Incidence of postoperative nausea and vomiting (PONV)
時間枠：During the first 24 hours
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During the first 24 hours
|
|
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Patient satisfaction
時間枠：Two hours after surgery
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Patient satisfaction, assessed using a Likert scale;
|
Two hours after surgery
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Pain recall
時間枠：two hours after surgery
|
Pain recall, evaluated by assessing patients' memory of the injection-related pain.
|
two hours after surgery
|
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 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Propofol pain injection
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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