内視鏡下副鼻腔手術を受ける患者の手術野の質に及ぼすトラネキサム酸の噴霧療法と静脈内トラネキサム酸の比較
内視鏡下副鼻腔手術を受ける患者の手術野の質に及ぼす術前噴霧トラネキサム酸と静脈内トラネキサム酸の影響:ランダム化比較比較研究
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Cairo Governorate
-
Cairo、Cairo Governorate、エジプト
- Faculty of Medicine, Cairo University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age between 18 and 60 years.
- American Society of Anesthesiologists (ASA) class I and II patients.
- Endoscopic sinus surgeries under general anesthesia.
Exclusion Criteria:
- Patient's refusal.
- American Society of Anesthesiologists (ASA) class III or IV patients.
- Underlying uncontrolled hypertension.
- Known history bleeding disorder.
- Patients on anticoagulant therapy.
- Allergy to any of the drugs utilized in this study.
- History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
- Inadvertent intra-operative vascular injury.
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:他の
- 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 |
|---|---|
|
アクティブコンパレータ:Nebulized group
patients will receive nebulized tranexamic acid |
patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline. |
|
アクティブコンパレータ:Intravenous group
patients will receive intravenous tranexamic acid |
patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session. |
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 |
|---|---|---|
|
The mean Wormald intraoperative surgical field grading
時間枠:5 hours
|
The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly |
5 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total blood loss
時間枠:5 hours
|
calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field |
5 hours
|
|
Bleeding rate
時間枠:5 hours
|
calculated as the total blood loss divided by the surgical time |
5 hours
|
|
Operation time
時間枠:5 hours
|
Time starting from induction of anesthesia till completion of the surgical procedure |
5 hours
|
|
Postoperative complications
時間枠:24 hours
|
nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism |
24 hours
|
|
postoperative nasal bleeding
時間枠:48 hours
|
Incidence of postoperative nasal bleeding |
48 hours
|
|
postoperative intervention
時間枠:48 hours
|
Incidence of the need for postoperative intervention to control nasal bleeding |
48 hours
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Kareem MA Nawwar, M.D.、Cairo University
- スタディチェア:Nevan M Abbas Elmekawy, M.D.、Cairo University
- スタディディレクター:Tamer M Khair, M.D.、Cairo University
- 主任研究者:Nadia E M Gaballah, M.Sc.、Cairo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- MD-206-2024
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
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。