Nociception Level Index Monitoring During Cesarean Section (NOL-CS)
Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
調査の概要
状態
条件
詳細な説明
Postoperative pain following cesarean section remains an important clinical concern because inadequate analgesia may delay maternal recovery, increase opioid consumption, and negatively affect early breastfeeding and maternal-infant bonding. Conventional intraoperative monitoring does not directly assess nociceptive responses, making individualized analgesic administration challenging.
The Nociception Level (NOL) index is a multiparametric monitoring system that integrates photoplethysmography, galvanic skin response, peripheral temperature, and accelerometer signals to provide an objective assessment of nociception during anesthesia. This technology may enable more individualized opioid administration based on the patient's nociceptive response.
In this prospective randomized controlled trial, patients undergoing elective cesarean section under general anesthesia were randomized to receive either NOL-guided intraoperative analgesia or standard intraoperative monitoring. In the intervention group, fentanyl administration after fetal delivery was guided by the NOL index, whereas patients in the control group received conventional hemodynamic-guided analgesia.
Postoperative pain was evaluated using the visual analog scale (VAS) at predefined time points during the first 24 postoperative hours. Rescue opioid requirements, total postoperative analgesic consumption, and time to first breastfeeding were also recorded. The study was designed to determine whether NOL-guided analgesia could improve early postoperative pain control and reduce postoperative opioid requirements compared with conventional monitoring.
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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Sultangazi
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Istanbul、Sultangazi、トルコ（Türkiye）、34256
- University of Health Sciences Türkiye Haseki Training and Research Hospital
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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:
- Female patients undergoing elective cesarean section under general anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:
- Refusal to participate.
- Emergency cesarean section.
- High-risk pregnancy (including hypertensive disorders of pregnancy, diabetes mellitus, preterm labor, or fetal growth restriction).
- Placental abnormalities.
- History of allergy to any study medication.
- History of malignant hyperthermia.
- Alcohol or substance abuse.
- Severe cardiac disease or severe arrhythmia.
- Peripheral vascular disease.
- Renal or hepatic failure.
- Contraindication to corticosteroid administration.
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：処理
- 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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実験的：NOL-Guided Analgesia Group
Patients undergoing elective cesarean section under general anesthesia were monitored intraoperatively using the Nociception Level (NOL) index in addition to standard monitoring.
After fetal delivery, fentanyl was administered in 25-mcg boluses when the NOL value remained above 25 for more than 1 minute, with a minimum interval of 5 minutes between doses.
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The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
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アクティブコンパレータ：Standard Monitoring Group
Patients undergoing elective cesarean section under general anesthesia received standard intraoperative monitoring.
Intraoperative analgesic management was performed according to conventional clinical practice without NOL index guidance.
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Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index guidance.
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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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Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
時間枠：10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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Postoperative pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 indicated the worst imaginable pain.
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10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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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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Time to first breastfeeding
時間枠：Within the first postoperative hour
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The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.
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Within the first postoperative hour
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Need for rescue analgesia
時間枠：Within the first 24 hours after surgery
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The proportion of patients requiring additional postoperative analgesia was recorded.
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Within the first 24 hours after surgery
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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
キーワード
その他の研究ID番号
- HASEKI-36-408-2023
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
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。
Nociception Level Index Monitoringの臨床試験
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Marmara University募集漏斗胸 | 胸部の変形トルコ（Türkiye）
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Marmara University募集