Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis A Prospective Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- intraoperative analgesic effectiveness, Measured by Heart Rate
研究概览
简要总结
Opioid-free anesthesia (OFA) is a multimodal analgesic approach designed to eliminate the intraoperative use of systemic, neuraxial, or intracavitary opioids. This technique employs a combination of antinociceptive agents targeting various pathways within the central and peripheral nervous systems to achieve effective analgesia.
Dexmedetomidine (DEX), a highly selective α2-adrenoreceptor agonist, is a centrally acting non-opioid agent increasingly utilized in clinical practice for its antinociceptive and anxiolytic properties. Only a few prospective randomized controlled trials have specifically examined the postoperative analgesic efficacy of intraoperative dexmedetomidine infusion in patients undergoing spinal surgery, with limited data focusing on this as a primary endpoint. Importantly, no clinical studies have investigated its analgesic impact in patients undergoing spinal surgery under general anesthesia.
详细描述
Reducing perioperative opioid exposure presents a critical opportunity for anesthesiologists, surgeons, and institutions to minimize patient harm and improve recovery outcomes. Opioid-free anesthesia (OFA) has emerged as a promising approach to address this need. Opioid-free anesthesia is defined as an anesthetic technique that excludes intraoperative opioid administration through all routes including systemic, neuraxial, and local tissue infiltration relying instead on multimodal non-opioid strategies to achieve effective analgesia. (5) Aim This study explores the intraoperative and postoperative application of dexmedetomidine (DEX) as an opioid-free anesthetic strategy to improve perioperative outcomes in patients undergoing scoliosis surgery under general anesthesia.
Hypothesis:
Continuous infusion of Dexmedetomidine at 0.5 μg/kg/h, following an initial loading dose of 1 μg/kg, yields more effective than standard approaches.
Outcomes This prospective randomized controlled study investigates the intraoperative and postoperative efficacy of dexmedetomidine (DEX) infusion in patients undergoing scoliosis surgery. The primary outcome is intraoperative analgesic effectiveness, while secondary outcomes include the incidence of perioperative complications, the requirement for rescue fentanyl, and surgeon satisfaction.
Thirty patients will be prospectively enrolled and randomly allocated into two parallel groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients younger than 18 years of age, classified as American Society of Anesthesiologists (ASA) Physical Status I or II, and will be scheduled for surgical correction of adolescent idiopathic scoliosis.
排除标准
- •Refusal to participate in the study or to allow use of personal data
- •Non-idiopathic scoliosis
- •Contraindications to commonly used perioperative medications
- •ASA Physical Status ≥ III
- •Presence of neuromuscular disorders or severe cardiac dysfunction
- •Requirement for postoperative mechanical ventilation
- •Regular use of analgesics or opioids
- •History of allergy to opioids or dexmedetomidine
- •Diagnosed mental disorders
- •Severe hepatic or renal dysfunction
- •Coagulopathy or significant pulmonary disease
- •Preoperative or postoperative neurological deficits
- •Occurrence of serious arrhythmia, hypotension, or bradycardia necessitating discontinuation of dexmedetomidine infusion
研究组 & 干预措施
Group OFA (Opioid-Free Anesthesia):
干预措施: Dexmedetomidine (Drug)
Group OBA (Opioid-Based Anesthesia)
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
intraoperative analgesic effectiveness, Measured by Heart Rate
时间窗: 2 hours
Changes in heart rate recorded at predefined intraoperative intervals to assess physiological response to analgesia.
intraoperative analgesic effectiveness, Measured by blood pressure
时间窗: 2 hours
Changes in blood pressure recorded at predefined intraoperative intervals.
次要结局
- the requirement for rescue fentanyl(24 hour)
- surgeon satisfaction(2 hours)
- Assessment of Intraoperative Blood Loss(2 hours)
- hemodynamics(2 hours)
- Quality of surgical field(2 hours)
研究者
Nashwa Ahmed
, Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt
Port Said University hospital