The Efficacy of Adding Dexmedetomidine Perineurally to Bupivacaine in Ultrasound Guided Fascia Iliaca Block Versus Intravenously Infused Dexmedetomidine on Hemodynamic Stability Intraoperatively and Postoperative Analgesia Following Hip Arthroscopy
調査の概要
状態
条件
詳細な説明
This study is a randomized controlled trial at Ain Shams university hospital, Cairo, Egypt. The study will include 88 patients (44 patients) in each group planned for undergoing hip arthroscopy under general anesthesia, will be randomly assigned into one of the following two groups using computer generated codes and opaque sealed envelopes:
All patients will range from ASA I or II, planned for elective hip arthroscopy, aging from 18 to 65 years, body weight renge from 70- 80 Kg of both sexes.
Patients will receive 0.03 mg/kg intravenous (IV) midazolam as a preanesthetic medication, and 1 mg Granisetron as a postoperative nausea and vomiting (PONV) prophylaxis after application of routine monitoring (electrocardiogram, non-invasive blood pressure monitoring and oxygen saturation (SPO2)).
A standard anaesthetic technique will be followed. After preoxygenation for three minutes, anaesthesia will be induced with: propofol 2-3 mg/kg, fentanyl 1µg/kg. Atracuirium besilate 0.5 mg/kg will be used to provide muscle relaxation. All patients will be mechanically ventilated with a tidal volume of 8 ml/kg. 1-2 minimum alveolar concentration (MAC) of isoflurane mixed with oxygen (50%) and air (50%) will be used for maintenance of anesthesia.
GROUP A will receive Dexmedetomidine in dose of of 0.5μg/ kg/hour It elicits a biphasic blood pressure response: a short hypertensive phase followed by hypotension. It is expected that the decreased blood pressure and heart rate, will happen with ongoing therapy within 15 minutes, mediated by central α2A-AR, that decrease the release of noradrenaline from the sympathetic nervous system (10) And that is the reason we will start Dexmedetomidine infusion just after intubation.
Then Ultrasound-guided block was performed in supine position, inguinal ligament was identified, and crease area was sterilized using povidone iodine. Using a 7.5 -12 MHz linear probe, started on the inguinal crease parallel to the inguinal ligament, and after identification of femoral artery, a little movement of the probe laterally till iliopsoas muscle was specified as a hypo echo part in lateral to the artery and femoral nerve. It is covered by a hyperechoic fascia, which separates the muscle from the subcutaneous tissue, using the in-plane technique a 22G/80 mm insulated echogenic block needle was inserted and advanced towards the fascia iliaca and iliopsoas muscle. Confirming the passage of the needle through the fascia iliaca using fascial click and 2mL of saline. LA was injected between fascia iliaca and iliopsoas muscle, we used ultrasound guided hydro dissection technique. Through this hydro dissection, the needle was moved towards the space created by the injected LA. The responsible anesthesiologist and the patient were unaware of the nature of drug in each syringe and master codes were stored by personnel who did not participate in observation.
Mean arterial blood pressure (MABP) and heart rate (HR) will be measured. Any increase or decrease in HR or blood pressure, will be managed as required after exclusion of a surgical cause. For example, MABP or HR rise of > 20% above baseline will be treated by administering a 0.5 μg/kg intravenous bolus of fentanyl.
MABP drop of > 20% below baseline will be dealt with reduction of the isoflurane concentration to 0.6%. If patient is still hypotensive, 6 mg ephedrine will be given intravenously. Finally, bradycardia will be treated with: 0.6 mg IV atropine bolus and repeated as required.
Fentanyl (0.5µg/kg IV) will be titrated intraoperatively at the discretion of the attending anaesthesiologists up to one hour prior to the end of surgery. No other intraoperative adjunct analgesic will be given.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Cairo、エジプト
- maha sadek El Derh
-
-
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:
- Patients undergoing elective hip arthroscopy.
- ASA I and II patients
- aged 18 to 65 years,
- 70-80 kg,
both sexes.
- Exclusion Criteria:
- Refusal of the patient to receive FICB or to participate in the study,
- Impaired renal or hepatic functions,
- Asthmatic patients.
- Patients with multiple traumas.
- Obese patients with Body Mass Index > 35.
- Allergy to study drugs.
- Patients with local infection.
- Previous surgery at the injection area.
- Bleeding disorders.
- Patients on anticoagulant therapy,
- Addicts.
- Patients with an opioid analgesic prescription within the last 2 h before the operation.
- Peripheral neuropathy,
- Mental and or psychiatric disorders.
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:支持療法
- 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 |
|---|---|
|
アクティブコンパレータ:Active:Group A
Group A: receive 40 ml bupivacaine 0.25% +5 ml placebo in FICB perineurally in generally anaesthetized patients with intravenous infusion of 0.5 µg/kg/h of Dexmedetomidine.
|
Arm 1; Bupivacaine hydrochloride 40 ml 0.25% perineurally in FICB
他の名前:
Arm 1: infusion of Dexmedetmidine 0.5 µg/kg/h
他の名前:
|
|
アクティブコンパレータ:(Group B
Group B: receive FICB with dexmedetomidine 80µg diluted in 5 ml normal saline and 40 ml bupivacaine 0.25% added perineurally in generally anaesthetized patients without dexmedetomidine infusion.
|
Arm 1; Bupivacaine hydrochloride 40 ml 0.25% perineurally in FICB
他の名前:
Arm 2:Dexmedetomidine perineurally in FICB 80µg
他の名前:
|
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 |
|---|---|---|
|
Effect of dexmedetomidine infusion
時間枠:introperative
|
incidence of need rescue agents (fentanyl) intraoperatively and the rate change in heart rate ang blood pressure
|
introperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual Analogue scale (VAS)
時間枠:24 hours postoperative
|
incidence of need of postoperative analgesic (pethidine) , time of first request and the total dose VAS Will be recorded at 2, 3, 4, 6, 8, 12, 18 and 24 hours.
Pethidine 20 mg was administered IV as rescue analgesic if VAS pain score was more than 3 or the patient asked for analgesia and can be repeated after 20 minutes till VAS≤3.
The time to first analgesic request and 24 hours total analgesic requirement were recorded and compared.
Also, fixed dose of 1 g intravenous acetaminophen will be given /8h.
|
24 hours postoperative
|
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- FMASU R 116/2021
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
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