A Randomized Comparative Study of Opioid-Free Versus Opioid-Based Anesthesia in Laparoscopic Cholecystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (VAS)
研究概览
简要总结
This study was a single-center, prospective, randomized clinical trial designed to compare the effects of opioid-free anesthesia (OFA) with standard opioid-based anesthesia during elective laparoscopic cholecystectomy. The aim was to evaluate the impact of these two anesthetic approaches on postoperative pain, analgesic requirement, hemodynamic stability, postoperative nausea and vomiting (PONV), and recovery quality.
A total of 101 patients, aged 18 to 65 years and classified as ASA I-II, undergoing elective laparoscopic cholecystectomy were enrolled and randomized into two groups. The OFA group received intravenous lidocaine and dexmedetomidine, while the standard anesthesia (RA) group received a remifentanil-based protocol. All other anesthetic agents and surgical procedures were standardized across both groups.
Intraoperative monitoring included heart rate, systolic and diastolic blood pressure, and end-tidal CO₂, recorded at 5-minute intervals. Postoperative assessments included visual analog scale (VAS) pain scores at multiple time points (10, 20, 30, 60 minutes; 2, 12, and 24 hours), rescue analgesic use, incidence of PONV, and Modified Aldrete Scores at 0, 30, and 60 minutes.
The results demonstrated that patients in the OFA group experienced significantly lower VAS pain scores in both early and late postoperative periods. The OFA group also required less rescue analgesia, had lower heart rate and blood pressure readings postoperatively, and showed a reduced incidence of PONV. Additionally, recovery parameters such as shorter time to extubation and higher early Aldrete scores favored the OFA group.
These findings suggest that opioid-free anesthesia using lidocaine and dexmedetomidine is a safe and effective alternative to opioid-based anesthesia in laparoscopic cholecystectomy. It provides better postoperative pain control, reduces opioid-related side effects, and improves overall recovery. The study supports the potential for integrating OFA into enhanced recovery protocols and calls for further multicenter trials with larger sample sizes to validate and generalize the results.
详细描述
Postoperative pain remains a major clinical concern, affecting recovery, patient comfort, and hospital resource utilization. Traditionally, opioids have played a central role in intraoperative and postoperative pain management. However, opioid use is associated with several adverse effects such as respiratory depression, nausea, vomiting, sedation, ileus, tolerance, hyperalgesia, and dependency. These drawbacks have driven interest in alternative strategies that reduce or eliminate perioperative opioid exposure, particularly within the framework of Enhanced Recovery After Surgery (ERAS) protocols.
Opioid-Free Anesthesia (OFA) is a multimodal approach that omits opioids and instead utilizes a combination of non-opioid agents such as lidocaine, dexmedetomidine, ketamine, NSAIDs, and magnesium sulfate to provide analgesia, hemodynamic stability, and sedation. OFA aims to minimize opioid-related side effects while maintaining effective pain control and facilitating faster recovery.
This single-center, prospective, randomized controlled trial was designed to compare OFA using intravenous lidocaine and dexmedetomidine to standard general anesthesia with remifentanil in patients undergoing elective laparoscopic cholecystectomy. The primary aim was to assess the effect of OFA on postoperative pain scores and rescue analgesia requirement. Secondary outcomes included intraoperative hemodynamic parameters, postoperative nausea and vomiting (PONV), and recovery quality assessed via Modified Aldrete Scores.
A total of 101 adult patients, aged 18-65 years, classified as ASA I-II, were enrolled and randomized into two groups:
OFA Group: Received intravenous lidocaine (1.5 mg/kg bolus followed by infusion at 1.5 mg/kg/h) and dexmedetomidine (0.5 μg/kg loading dose followed by 0.5 μg/kg/h infusion).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Elective laparoscopic cholecystectomy
- •Informed consent
- •BMI 18-30 kg/m²
- •Normal liver and renal function
排除标准
- •Refusal to participate
- •Allergy to study drugs
- •Chronic opioid use
- •Major organ disease
- •Pregnancy or lactation
- •Open surgery conversion
- •Recent participation in another trial
研究组 & 干预措施
Opioid-Free Anesthesia (OFA)
Participants in this group received intravenous lidocaine and dexmedetomidine for opioid-free anesthesia. Lidocaine was administered as a 1.5 mg/kg bolus followed by a continuous infusion of 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by an infusion of 0.5 µg/kg/h. No opioids were used intraoperatively. Standard induction with propofol and muscle relaxation with rocuronium were applied.
干预措施: Lidocaine + Dexmedetomidine (Drug)
Opioid-Based Anesthesia (RA)
Participants in this group received standard general anesthesia with remifentanil infusion at 0.1-0.5 µg/kg/min. Anesthesia induction was performed using propofol and rocuronium. All other surgical and anesthetic parameters were standardized to match those of the OFA group.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Postoperative Pain Score (VAS)
时间窗: 0-24 hrs
VAS at multiple time points post-surgery
次要结局
- Hemodynamic Monitoring(Intraoperative)
- Rescue Analgesic Use(0-24 hrs)
- Recovery Score (Aldrete)(0, 30, 60 min post-extubation)
- PONV Incidence(0-24 hrs)
- Extubation Time(Immediately after surgery)
研究者
Gorkem Tukenmez
Resident Physician, Department of Anesthesiology and Reanimation
Dr. Lutfi Kirdar Kartal Training and Research Hospital