A Prospective Randomized Double-Blinded Study to Evaluate the Efficacy, Safety, and Feasibility of Opioid-Free Anaesthesia in Laparoscopic Surgeries During the Peri and Post Operative Period
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the feasibility and efficacy of opioid-free anesthesia during the intraoperative period by monitoring vitals and BIS (Bispectral Index) scores.
研究概览
简要总结
This prospective, randomized, double-blinded study aims to evaluate the efficacy, safety, and feasibility of Opioid-Free Anaesthesia (OFA) in laparoscopic surgeries. The study will compare OFA, which includes Lidocaine, Magnesium, and Erector Spinae Plane Block (ESPB), with Standard Opioid-Based Anaesthesia (SOBA) using conventional opioids. The primary outcome measures include hemodynamic stability, BIS scores, and intraoperative analgesic requirements. Secondary outcomes focus on postoperative pain (VAS scores), time to first analgesic request, total postoperative analgesic consumption, incidence of adverse effects, and recovery parameters. A total of 100 adult patients will be recruited and followed for 24 hours postoperatively. The study aims to determine whether OFA can provide effective perioperative pain management while reducing opioid-related side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants eligible for inclusion in the study must meet the following criteria: Age Range: 18 to 60 years ASA Classification: American Society of Anesthesiologists (ASA) Grade I and II Elective Laparoscopic Surgery: Patients scheduled for laparoscopic cholecystectomy, appendectomy, or hernia repair Ability to Provide Informed Consent: Patients who understand and voluntarily agree to participate in the study Hemodynamically Stable Patients: No pre-existing severe cardiovascular instability.
排除标准
- 未提供
结局指标
主要结局
To study the feasibility and efficacy of opioid-free anesthesia during the intraoperative period by monitoring vitals and BIS (Bispectral Index) scores.
时间窗: 1. Intraoperative Time Points (During Surgery) | Baseline (Before Induction) | At specific intervals after induction: | 0 min | 1 min | 5 min | 10 min | 15 min | 30 min | 45 min | 60 min | 75 min | 90 min | 105 min | 120 min | 135 min | 150 min | 2. Postoperative Time Points (After Surgery) | Immediately after extubation | Follow-up monitoring at: | 0 hours (immediate post-op) | 15 minutes | 30 minutes | 1 hour | 2 hours | 4 hours | 8 hours | 12 hours | 24 hours
This means the study primarily focuses on assessing how well opioid-free anesthesia maintains hemodynamic stability (heart rate, blood pressure, oxygen saturation, etc.) and the depth of anesthesia (via BIS monitoring) during surgery.
时间窗: 1. Intraoperative Time Points (During Surgery) | Baseline (Before Induction) | At specific intervals after induction: | 0 min | 1 min | 5 min | 10 min | 15 min | 30 min | 45 min | 60 min | 75 min | 90 min | 105 min | 120 min | 135 min | 150 min | 2. Postoperative Time Points (After Surgery) | Immediately after extubation | Follow-up monitoring at: | 0 hours (immediate post-op) | 15 minutes | 30 minutes | 1 hour | 2 hours | 4 hours | 8 hours | 12 hours | 24 hours
次要结局
- The secondary outcome measures include postoperative pain assessment, time to first analgesic request, total postoperative analgesic consumption, incidence of postoperative adverse effects, and postoperative recovery parameters. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points. The total dose of rescue analgesia required within the first 24 hours will be recorded. Adverse effects such as nausea, vomiting, sedation, and respiratory depression will be monitored. Recovery parameters, including time to ambulation and time to discharge from PACU, will also be evaluated(Postoperative pain (VAS score) will be measured at 0, 15, and 30 minutes, and at 1, 2, 4, 6, 8, 12, and 24 hours.)
研究者
Dr Divyalakshmi T
Vinayaka Missions Kirupananda Variyar Medical College