Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.
調査の概要
詳細な説明
Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.
If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.
At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.
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
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Jeollabukdo
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Iksan、Jeollabukdo、大韓民国、54538
- Wonkwag UH
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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:
- Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
- American Society of Anesthesiologists' physical status class (ASA) award class I-III.
Exclusion Criteria:
- Patients with fever before surgery
- Patients taking antipyretics before surgery
- Patients who are chronically using anti-inflammatory drugs
- High-risk patients with ASA class IV or higher
- Patient who refused sedation
- Patients with thyroid dysfunction.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Group P
The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).
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Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
他の名前:
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実験的:Group R
The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).
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Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
他の名前:
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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 |
|---|---|---|
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The incidence of perioperartive hypothermia
時間枠:During surgery
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Measure the body temperature on the tympanic membrane three times and enter the highest value.
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During surgery
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The incidence of perioperartive hypothermia
時間枠:At PACU (Post Anesthesia Care Unit)
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measure the body temperature three times on the tympanic membrane and enter the highest value.
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At PACU (Post Anesthesia Care Unit)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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core body temperature
時間枠:Before the induction of anesthesia
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Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
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Before the induction of anesthesia
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core body temperature
時間枠:During surgery
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Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
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During surgery
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core body temperature
時間枠:At PACU
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Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
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At PACU
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shivering grades
時間枠:During surgery
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During surgery
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shivering grades
時間枠:At PACU
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At PACU
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協力者と研究者
捜査官
- 主任研究者:Cheolhyeong Lee, M.D.、Wonkwang University Hospital
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
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