Multimodal Opioid-Free Anesthesia in RIRS
Multimodal Opioid-Free Anesthesia in RIRS: A Comparison of Dexmedetomidine-Ketamine Combination Versus Conventional Opioid-Based Protocols
The goal of this clinical trial is to evaluate whether a dexmedetomidine-ketamine based opioid-free anesthesia (OFA) protocol can provide effective analgesia compared to conventional fentanyl-based anesthesia in adult patients undergoing elective retrograde intrarenal surgery (RIRS). The main questions it aims to answer are:
Does opioid-free anesthesia reduce postoperative opioid consumption compared to fentanyl-based anesthesia? Does opioid-free anesthesia result in lower postoperative pain scores?
Researchers will compare the dexmedetomidine-ketamine group to the fentanyl-based anesthesia group to see if opioid-free anesthesia reduces opioid requirements and improves recovery quality.
Participants will receive either a dexmedetomidine-ketamine based OFA protocol or conventional fentanyl-based anesthesia during surgery and will be monitored for pain, opioid consumption, and recovery outcomes postoperatively.
調査の概要
状態
詳細な説明
Opioids have traditionally been the cornerstone of perioperative analgesia; however, opioid-related adverse effects such as respiratory depression, postoperative nausea and vomiting (PONV), opioid-induced hyperalgesia, sedation, and delayed recovery may negatively affect postoperative outcomes. Opioid-free anesthesia (OFA) is a multimodal anesthetic approach that aims to provide adequate analgesia while minimizing or eliminating perioperative opioid exposure.
Dexmedetomidine and ketamine are commonly used components of OFA protocols. Dexmedetomidine provides sedation and analgesia through selective alpha-2 adrenergic receptor agonism without significant respiratory depression, whereas ketamine reduces central sensitization and opioid-induced hyperalgesia through NMDA receptor antagonism. Their combined use may provide synergistic analgesic and hemodynamic effects.
Retrograde intrarenal surgery (RIRS) is a minimally invasive endourological procedure commonly performed for renal stone disease. Rapid postoperative recovery and early discharge are important goals in this patient population. The use of laryngeal mask airway (LMA) may further facilitate smoother airway management and recovery.
This prospective, randomized, single-center, assessor-blinded clinical trial will compare a dexmedetomidine-ketamine based OFA protocol with conventional fentanyl-based anesthesia in adult patients undergoing elective RIRS under LMA. Eligible participants will be randomized in a 1:1 ratio to either the opioid-free anesthesia group or the opioid-based anesthesia group.
The primary outcomes are postoperative pain scores assessed using the Numeric Rating Scale (NRS) and postoperative opioid consumption during the early recovery period. Secondary outcomes include recovery characteristics, intraoperative hemodynamic parameters, quality of LMA removal, intraoperative patient movement, postoperative nausea and vomiting, surgeon satisfaction, and perioperative adverse events.
The investigators hypothesize that the OFA protocol may reduce postoperative opioid requirements and improve recovery quality while maintaining adequate perioperative analgesia and hemodynamic stability.
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:MURAT SAHIN
- 電話番号:+905070666680
- メール:mrtshn52@gmail.com
研究連絡先のバックアップ
- 名前:Omer Faruk Bilin
- 電話番号:+905383975966
研究場所
-
-
Muş
-
Muş、Muş、トルコ(Türkiye)、49100
- Mus State Hospital
-
コンタクト:
- MURAT SAHIN
- 電話番号:+905070666680
- メール:mrtshn52@gmail.com
-
-
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:
Aged 18 to 65 years ASA physical status I or II ASA III patients with controlled and stable systemic disease (e.g., well-controlled hypertension or type 2 diabetes without end-organ damage) Scheduled for elective retrograde intrarenal surgery (RIRS) under laryngeal mask airway (LMA) Ability to provide written informed consent
Exclusion Criteria:
BMI greater than 40 kg/m² Chronic opioid use Severe cardiovascular disease (uncontrolled arrhythmia, unstable angina, or ejection fraction below 40%) Significant respiratory disease (FEV1 below 60% predicted or oxygen-dependent COPD) Neuropsychiatric disorders Pregnancy Known allergy to any study drug Anticipated difficult airway (Mallampati III-IV, mouth opening less than 3 cm, or thyromental distance less than 6 cm) Requirement for conversion from LMA to endotracheal intubation Emergency cases Withdrawal of 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: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 |
|---|---|
|
実験的:Opioid-Free Anesthesia Group
Participants receive an opioid-free anesthesia protocol consisting of dexmedetomidine infusion and ketamine administration during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA).
|
Opioid-free anesthesia protocol using dexmedetomidine infusion and ketamine administration without intraoperative opioid use.
|
|
アクティブコンパレータ:Opioid-Based Anesthesia Group
Participants receive conventional fentanyl-based anesthesia during elective retrograde intrarenal surgery (RIRS) performed under laryngeal mask airway (LMA).
|
Conventional opioid-based anesthesia protocol using fentanyl during surgery.
|
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 |
|---|---|---|
|
Postoperative Pain Intensity
時間枠:Within 60 minutes postoperatively
|
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at PACU arrival, 30 minutes, and 60 minutes postoperatively.
|
Within 60 minutes postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Opioid Consumption
時間枠:Within 60 minutes postoperatively
|
Total postoperative tramadol consumption during the early postoperative recovery period.
|
Within 60 minutes postoperatively
|
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
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
- 1249
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。