Sriganesh Kamath, Syeda Seham, Shanthanna Harsha, Venkataramaiah Sudhir, Palaniswamy Sangeetha R
Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, India.
Department of Anaesthesia, McMaster University, Hamilton, ON, Canada.
Int J Clin Pract. 2019 Jun;73(6):e13338. doi: 10.1111/ijcp.13338. Epub 2019 Mar 21.
Moderate to severe pain is common despite the use of potent opioids during craniotomies. Non-opioid agents such as dexmedetomidine reduce undesirable opioid effects and are successfully used as primary analgesic during bariatric surgeries. This study assessed the feasibility of conducting a large randomised controlled trial comparing fentanyl with dexmedetomidine for perioperative analgesia during craniotomy.
This was a prospective single-centre randomised controlled feasibility trial. Twenty-four consenting adult patients undergoing supratentorial craniotomy at NIMHANS, Bangalore, India, were recruited after ethical approval in March and April 2018. They received either fentanyl 1 µg kg h (n = 12) or dexmedetomidine 0.5 µg kg h (n = 12) as primary intraoperative analgesic drug. Patient, anaesthesiologist, outcome assessor and data analyst were blinded to the study intervention. Our feasibility outcomes (primary) were recruitment and adherence rates. We also explored the potential efficacy of intervention and adverse events.
We recruited 24 out of 30 eligible patients and had 100% protocol adherence, thereby demonstrating the feasibility of a larger randomised controlled trial. All 24 patients completed the study. The demographic and clinical parameters were similar between the groups. Compared between fentanyl and dexmedetomidine, there was no difference in the intraoperative fentanyl (top-up) consumption (µg), expressed as median and interquartile range: 25 (0-50) and 0 (0-50); P = 0.844; and no difference in postoperative pain at 15 and 60 minutes. Adverse events were few and similar with fentanyl and dexmedetomidine.
A large-scale randomised controlled trial of perioperative dexmedetomidine versus fentanyl is feasible. Dexmedetomidine has the potential to be non-inferior to fentanyl for perioperative analgesia during craniotomies.
尽管在开颅手术中使用了强效阿片类药物，但中度至重度疼痛仍很常见。右美托咪定等非阿片类药物可减少不良阿片类药物效应，并成功用于减重手术的主要镇痛。本研究评估了开展一项大型随机对照试验的可行性，该试验比较芬太尼与右美托咪定在开颅手术围手术期镇痛中的效果。
这是一项前瞻性单中心随机对照可行性试验。2018年3月和4月获得伦理批准后，在印度班加罗尔的国家精神卫生和神经科学研究所招募了24名接受幕上开颅手术的成年患者并获得其同意。他们分别接受芬太尼1µg·kg·h（n = 12）或右美托咪定0.5µg·kg·h（n = 12）作为术中主要镇痛药物。患者、麻醉医生、结局评估者和数据分析师对研究干预均不知情。我们的可行性结局（主要指标）是招募率和依从率。我们还探讨了干预的潜在疗效和不良事件。
我们从30名符合条件的患者中招募了24名，协议依从率为100%，从而证明了开展更大规模随机对照试验的可行性。所有24名患者均完成了研究。两组间的人口统计学和临床参数相似。芬太尼组与右美托咪定组相比，术中芬太尼（追加）用量（µg）无差异，中位数和四分位间距分别为：25（0 - 50）和0（0 - 50）；P = 0.844；15分钟和60分钟时的术后疼痛也无差异。不良事件较少，芬太尼组和右美托咪定组相似。
开展一项围手术期右美托咪定与芬太尼对比的大规模随机对照试验是可行的。右美托咪定在开颅手术围手术期镇痛方面可能不劣于芬太尼。
