Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension
Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial
調査の概要
状態
条件
詳細な説明
Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing orthopedic hip surgery. Age-related physiological changes, impaired autonomic responses, and reduced cardiovascular reserve increase susceptibility to hypotension after subarachnoid block, which may result in organ hypoperfusion, myocardial ischemia, nausea, vomiting, and increased perioperative morbidity.
Phenylephrine is traditionally used for prevention and treatment of spinal anesthesia-induced hypotension because of its potent alpha-adrenergic vasoconstrictive effect. However, its use may be associated with reflex bradycardia and reduction in cardiac output. Norepinephrine, which possesses both alpha-adrenergic and mild beta-adrenergic activity, may provide better maintenance of heart rate and cardiac output while effectively preserving blood pressure.
This prospective randomized double-blinded clinical trial will be conducted at the Department of Anesthesia, Intensive Care and Pain Management, Sohag University Hospitals, after approval from the Institutional Ethics Committee. Elderly patients aged 60 years or older, classified as ASA physical status I-III and scheduled for elective orthopedic hip surgery under spinal anesthesia, will be enrolled after obtaining written informed consent.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Ahmed Abdelhamed Faress, Resident
- 電話番号：01065080913
- メール：drahmedfaress23896@gmail.com
研究連絡先のバックアップ
- 名前：Fawzy Abbas Badawy, Professor
研究場所
-
-
-
Sohag、エジプト
- 募集
- Sohag university hospital
-
コンタクト：
- Mohamed N Hamdoun, Professor
-
-
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:
- Age 60 years or older.
- ASA physical status I-III.
- Scheduled for elective hip surgery under subarachnoid block.
- Willing to provide written informed consent.
Exclusion Criteria:
- Patient refusal.
- Contraindications to subarachnoid block.
- Severe cardiac disease.
- Uncontrolled hypertension.
- Allergy to study drugs.
- Emergency surgery.
- Monoamine oxidase inhibitor use.
- Cognitive impairment preventing informed consent.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Norepinehrine group
• NE group: norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
|
実験的：Phenylepherine group
PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.
|
phenylephrine infusion at 100 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
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 |
|---|---|---|
|
Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring
時間枠：From the start of subarachnoid block until the end of surgery .
|
Heart rate will be continously monitored using standar electrocardiogram monitoring.
to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.
|
From the start of subarachnoid block until the end of surgery .
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of spinal anesthesia-induced hypotension
時間枠：From the administration of spinal anesthesia until the end of the procedure.
|
Defined as a decrease in mean arterial pressure (MAP) to <80% of baseline measurd by non-invasive blood pressure monitoring .
|
From the administration of spinal anesthesia until the end of the procedure.
|
|
Incidence of bradycardia
時間枠：Throughout the intraoperative period
|
Defined as heart rate ≤ 50 beats/min.
|
Throughout the intraoperative period
|
|
Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring
時間枠：Every 5 minutes from the start of spinal anesthesia until the end of surgery.
|
Monitoring the stability of blood pressure during vasopressor infusion
|
Every 5 minutes from the start of spinal anesthesia until the end of surgery.
|
|
Incidence of reactive hypertension measured by non-invasive blood pressure monitoring
時間枠：From the start of vasopressor infusion until the end of surgery.
|
Defined as mean arterial pressure (MAP) > 125% of baseline.
|
From the start of vasopressor infusion until the end of surgery.
|
|
Total intraoperative intavenous fluid
時間枠：At the end of the surgical procedure.
|
Total volume of intravenous fluids administered in milliliters
|
At the end of the surgical procedure.
|
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
追加の関連 MeSH 用語
その他の研究ID番号
- Soh-Med-26-5-9MS
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。