Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled Trial
Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo.
Adult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups:
- High-dose group: intravenous paracetamol 2 g
- Standard-dose group: intravenous paracetamol 1 g
- Control group: intravenous normal saline placebo
Each infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
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 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective lower-limb orthopedic surgery under spinal anesthesia
- Expected surgical duration between 1 and 3 hours
- Willingness to provide written informed consent
Exclusion Criteria:
- Patient refusal or inability to provide informed consent
- ASA physical status >= III
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at injection site, severe spinal deformity)
- Known allergy or hypersensitivity to paracetamol or the local anesthetic used
- Baseline (preoperative) core/tympanic temperature < 36.5°C or > 37.5°C
- Pre-existing hepatic, renal, or thyroid disorders
- History of seizure disorder
- Chronic alcohol use, malnutrition, or any condition predisposing to hepatotoxicity
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or lactation
- Chronic use of antipyretic or anti-inflammatory medication within 24 hours of surgery
- Cardiac arrhythmia or hemodynamic instability
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group H: High-Dose Paracetamol (2 g)
Patients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
アクティブコンパレータ：Group S: Standard-Dose Paracetamol (1 g)
Patients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
プラセボコンパレーター：Group C: Placebo Control
Patients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding. |
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 |
|---|---|---|
|
Percentage of Participants With Clinically Significant Post-Spinal Shivering
時間枠：Up to 4 hours post-spinal injection
|
Clinically significant shivering is defined as a shivering score >= 3 on the Crossley and Mahajan Shivering Grading Scale. The scale ranges from Grade 0 to Grade 4: Grade 0 = No shivering; Grade 1 = Piloerection or peripheral vasoconstriction without visible muscular activity; Grade 2 = Muscular activity confined to one muscle group; Grade 3 = Muscular activity involving more than one muscle group, but not generalized; Grade 4 = Gross muscular activity involving the whole body. Higher grades indicate greater shivering severity. |
Up to 4 hours post-spinal injection
|
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
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