Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Recruitment rate
研究概览
简要总结
Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.
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
- Double (Investigator, Outcomes Assessor)
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
- •Adults >/= 18 years.
- •Having elective major non-cardiac surgery (i.e., planned duration >/= 1.5 hours and anticipated >/= 1 night hospital stay).
- •Requiring general anesthesia.
- •Able to complete baseline quality of recovery assessment.
排除标准
- •Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
- •Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
- •Pregnant women.
- •Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
- •Neurosurgical procedures except for spine surgery.
- •Planned postoperative intubation after PACU discharge.
- •No fixed address.
研究组 & 干预措施
Intraoperative intravenous lidocaine
干预措施: lidocaine (Drug)
Intraoperative intravenous dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Usual care
干预措施: control group (Other)
结局指标
主要结局
Recruitment rate
时间窗: 1 week
Number of patients who are approached to participate by the study team and who consent to participate in the study.
次要结局
- Proportion of participants receiving dexmedetomidine(24 hours)
- Proportion of participants receiving lidocaine(24 hours)
- Completeness of data collection for outcome measures(6 months)
- Sex representativeness of participants(6 months)