Non-opioid versus Opioid Perioperative Analgesia In Neurosurgery: A prospective Multi-centric Randomized Controlled Trial (NO PAIN Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- 1.Rescue fentanyl consumption during surgery
研究概览
简要总结
Opioids are associated with unwanted adverse effects. Prolonged, overuse of opioid is a major public health problem across the world. In the healthcare setting, maximal opioid usage occurs during surgery and pain management. To overcome opioid-associated complications, alternatives to opioids are explored. Dexmedetomidine when added to opioid reduces the adverse effects and anesthetic and opioid consumption in neurosurgical patients. Our pilot study showed non-inferiority of dexmedetomidine (as primary non-opioid analgesic) to fentanyl (opioid analgesic) for perioperative pain management in neurosurgery. Hence, we intend to conduct this larger trial to confirm our preliminary findings. This will provide an effective and safe alternative to opioids for perioperative pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive consenting adult patients undergoing elective craniotomies for supratentorial brain tumors with Glasgow Coma Scale score of 15 will be included in this trial.
排除标准
- •We will exclude patients from this trial if they do not consent or if they have a current or past history of ischemic heart disease, cardiac failure (New York Heart Association grade ≥ 3), heart block or arrhythmia, untreated hypertension and diabetes mellitus, emergency surgery, pre-existing pain and receiving regular long-term drugs to manage pain, history of vomiting, previous cranial surgery, allergy to study drugs and opioid dependence as per the Diagnostic and Statistical Manual of mental disorders IV criteria.
结局指标
主要结局
1.Rescue fentanyl consumption during surgery
时间窗: 1.During surgery | 2.After surgery
2.Postoperative pain using Numerical Rating Scale score
时间窗: 1.During surgery | 2.After surgery
次要结局
- Patient satisfaction(24 hours after surgery)
- Persistent pain and quality of life(At 3 and 6 months after surgery)
- Adverse events(During and upto 60 minutes after surgery)
- Quality of sleep(1st postoperative day)
- Quality of recovery from anesthesia and emergence delirium(End of anesthesia till 60 minutes after surgery)