A COMPARATIVE STUDY BETWEEN OPIOID-FREE GENERAL ANAESTHESIA AND OPIOID-BASED GENERAL ANAESTHESIA ON THE QUALITY OF RECOVERY IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC HYSTRECTOMY: A Randomized Trial
調査の概要
状態
詳細な説明
This prospective randomised controlled study aims to evaluate the effects of opioid-free anaesthesia (OFA) compared with conventional opioid-based anaesthesia (OBA) in adult patients undergoing elective surgery under general anaesthesia. Eligible patients will be randomly assigned into two equal groups. The OFA group will receive a multi modal opioid-free anaesthetic regimen consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous infusions. The OBA group will receive fentanyl-based anaesthesia according to a standardised protocol. Both groups will receive similar induction agents, muscle relaxants, anti emetic prophylaxis, and postoperative analgesic regimens.
Preoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded intraoperatively and during the postoperative period. Postoperative recovery will be assessed using the SAMPE recovery room discharge checklist(Stability, Awake and Oriented, Motor, Pain, and Emesis) recovery room discharge checklist, an eight-item score assessing vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block. Patients will be discharged from the post-anaesthesia care unit (PACU) upon achieving a SAMPE score of 8.. Pain intensity will be evaluated using the Visual Analogue Scale (VAS) at predetermined postoperative time points (0, 1, 6, and 12 hours). The incidence and severity of postoperative nausea and vomiting (PONV) during the first 24 postoperative hours will be recorded and graded using a standardised PONV severity score. Additional outcomes include time to first rescue analgesia, total postoperative opioid consumption, and the occurrence of opioid-related adverse events such as postoperative hypoxemia.
Furthermore, serum interleukin-6 (IL-6) levels will be measured preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia as a biomarker of the surgical stress response. The study seeks to determine whether opioid-free anaesthesia can improve postoperative recovery, reduce PONV and opioid requirements, and attenuate the preoperative stress response compared with conventional opioid-based anaesthesia.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：yomna emad Youssef, MBBCH
- 電話番号：01026616629
- メール：yomnaelsayed@med.asu.edu.eg
研究連絡先のバックアップ
- 名前：yomna emad youssef, MBBCH
- 電話番号：01145211869
- メール：yomnayoussef95@gmail.com
研究場所
-
-
Abbasia
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Cairo、Abbasia、エジプト、00202
- Ain Shams
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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:
- Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia.
- Age group: 40-65 years old.
- BMI<35.
- ASA I-II.
Exclusion Criteria:
- Emergency hysterectomy.
- Allergy to any of the drugs used in the study.
- HR < 50 bpm (chronic treatment by beta blockers, heart block patients).
- Alcohol or drug abuse.
- Psychiatric disease.
- Liver impairment. Kidney impairment
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：ダブル
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：Opioid-Based Anaesthesia (OBA)
Participants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia.
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Fentanyl will be administered intravenously as the opioid component of balanced general anaesthesia. Loading dose of 2 mic/kg I.V. followed by continuous infusion of three syringes, one with fentanyl infusion 0.5mic/kg/hr, and two syringes with normal saline. will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4. |
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アクティブコンパレータ：Opioid-Free Anaesthesia (OFA) Group
Participants will receive opioid-free anaesthesia consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous intravenous infusions during surgery, in addition to standardized general anaesthesia.
|
Dexmedetomidine: Loading dose of 1 µg/kg IV over 10 min before induction, followed by continuous infusion at 0.4 µg/kg/h . Ketamine: Loading dose of 0.25mg/kg followed by continuous infusion of ketamine at 0.1mg/kg/hr . Lidocaine: loading dose of 1.5mg/kg/hr followed by maintainance of 1mg/kg/hr. All three infusions to be stopped 30 minutes before skin closure will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4. |
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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Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
時間枠：Within the first 24 hours postoperative.
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Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score.
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Within the first 24 hours postoperative.
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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 |
|---|---|---|
|
Postoperative Pain Score
時間枠：At 0, 1, 6, and 12 hours postoperative.
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Assessment of postoperative pain using the Visual Analogue Scale (VAS).
minimum better score 0 maximum worse score 10.
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At 0, 1, 6, and 12 hours postoperative.
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Time to First Rescue Analgesia
時間枠：Within the first 24 hours postoperative.
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Time elapsed from the end of surgery until the patient requires the first rescue analgesic.
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Within the first 24 hours postoperative.
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Total Postoperative Opioid Consumption
時間枠：Within the first 24 hours postoperative .
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Total amount of rescue opioid analgesics administered after surgery.
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Within the first 24 hours postoperative .
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Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )
時間枠：perioperative
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Assessment of recovery using the SAMPE(score of ambulatory patients in the recovery room ) discharge checklist evaluating vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block minimum worse score 0 maximum better score 8 .
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perioperative
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Prioperative Hemodynamic Parameters
時間枠：Intraoperatively and during the immediate postoperative period.
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Assessment of heart rate changes during and after surgery.
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Intraoperatively and during the immediate postoperative period.
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Serum Interleukin-6 (IL-6) Levels
時間枠：Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
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Measurement of serum IL-6 concentration as a biomarker of the perioperative stress response.
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Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
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Opioid-Related Adverse Events
時間枠：Within the first 24 hours postoperative.
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Incidence of opioid-related complications, including postoperative hypoxemia.
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Within the first 24 hours postoperative.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：yomna Emad Youssef、Ainshams University Hospitals
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
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 MD320/2025
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