Comparaison Entre anesthésie Avec épargne Morphinique guidée Par l'Index CARDEAN® et anesthésie Sans Morphinique au Cours Des Arthroplasties Totales de Hanche : étude randomisée
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Total dose of morphine required to maintain a pain score ≤ 3 on a numerical scale of 1 to 10 during the first 24 hours (dose expressed as oral morphine equivalent, OME)
研究概览
简要总结
The proposed study compares two anesthesia techniques; the hypothesis being tested is that titrating sufentanil based on the CARDEAN® index (titrated OSA) does not increase post-operative morphine consumption compared to opioid-free anesthesia (OFA). This CARDEAN®-guided titrated anesthesia approach could potentially allow for hospital discharge as early as 24 hours post-operatively and is compatible with ERAS protocols. The primary objective is to demonstrate that sufentanil administration guided by the CARDEAN® index (titrated OSA) does not increase postoperative morphine consumption compared to opioid-free anesthesia (OFA). This is a prospective, single-center, randomized, single-blind, non-inferiority study.
Two groups of 70 patients each (140 patients in total) are compared based on the type of intraoperative analgesia: titrated OSA (Arm 1) versus OFA (Arm 2).
Randomization will be performed at a 1:1 ratio and stratified by surgical approach (anterior or lateral approach).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Patient aged at least 18 years
- •Signed informed consent
- •American Society of Anesthesiologists (ASA) Class 1 to 3
- •Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure
- •Affiliated with or a beneficiary of a social security scheme.
排除标准
- •ASA Class 4 or 5
- •Emergency hip surgery
- •Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.)
- •Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index)
- •Resting bradycardia < 50 bpm
- •Second- or third-degree atrioventricular block
- •Chronic opioid user
- •Refusal of consent
- •Patient unable to read, write, or understand French
- •Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
- •Adult patient under guardianship, curatorship, or judicial protection
- •Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection
- •Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP
研究组 & 干预措施
Titrated Opioid Sparing Anesthesia
干预措施: Titrated Opioid Sparing Anesthesia (Procedure)
Opioid Free Anesthesia
干预措施: opioid free anesthesia (Procedure)
结局指标
主要结局
Total dose of morphine required to maintain a pain score ≤ 3 on a numerical scale of 1 to 10 during the first 24 hours (dose expressed as oral morphine equivalent, OME)
时间窗: During the first 24 hours after the start of anesthesia
次要结局
- IV morphine dose received in the PACU, expressed in MME(during the awakening)
- Maximum pain score on a 0-10 numerical rating scale (NRS max) at rest and during movement(On postoperative days 1 and 2)
- Stability of heart rate (HR) and mean arterial pressure (MAP)(During intervention)
- Speed of emergence from anesthesia in the post-anesthesia care unit (PACU)(Time interval between the end of the procedure and extubation)
- Postoperative pain control(During awakening, at day 1 and day 2 after surgery)
- Adverse effects of postoperative opioids(During the awakening)
- Discharge from the hospital is possible as early as 24 hours post-procedure for patients deemed eligible for early discharge (determined by the surgeon prior to the intervention).(Until 24 hours after surgery)
- Patient satisfaction: satisfaction questionnaire (completed on the day of discharge) regarding the management of any pain.(At discharge (between 24 and 48 hours after surgery))
- Morphine dose received in the surgical ward, expressed in MME, at 6, 12, 18, 24, 36, and 48 hours post-surgery (H0 = start of surgery)(Every 6 hours until 48 hours after surgery)
- Number of patients not receiving morphine in the PACU(during the awakening, 24 hours after surgery, 48 hours after surgery)
- Presence of postoperative nausea and/or vomiting (PONV)(Until up to 48 hours after surgery)
- Acute urinary retention (defined by the presence of a bladder volume > 600 ml requiring urinary catheterization)(Until up to 48 hours after surgery)
- Postoperative confusional state: preoperative cognitive test (Mini-Cog) and screening for postoperative confusional state (Confusion Assessment Method, CAM)(After surgery just before discharge (between 24 and 48 hours after surgery))