Farhadi Kousha, Rahimi Mojgan, Varpaei Hesam, Rajabi Erta, Tafreshi Seyyed Mohammad Mahdi Tayebi, Mohammadi Parsa, Mohammadi Mostafa
Anesthesia, Critical Care, and Pain Management Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Department of Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Perioper Med (Lond). 2025 Aug 22;14(1):90. doi: 10.1186/s13741-025-00571-3.
This study aimed to examine the feasibility and effects of preoperative 5 mg of melatonin and intraoperative 50 mg of ketamine on postoperative delirium (POD) prevention in candidates for colorectal cancer surgery.
In this randomized controlled trial, adults (> 18 years) who were candidates for elective colorectal cancer surgery were included in the study. Patients were randomized into four groups: placebo/saline (PS), melatonin/saline (MS), placebo/ketamine (PK), and melatonin/ketamine (MK). The groups received either 5 mg of oral melatonin or a placebo the night before surgery and 50 mg of ketamine or normal saline after anesthesia induction. The occurrence and severity of POD and pain severity were assessed via the confusion assessment method for the intensive care unit (CAM-ICU) and visual analogue scale (VAS), respectively (twice daily), until postoperative day 4.
One-hundred and four patients (51% male, mean age: 56.29 ± 12.65) with a rate of 4.7 patients per week were recruited, with an attrition rate of 13.3%. The prevalence of POD was 17.3%, 22.23%, 16.67%, and 16.67% in the PS group, the MS group, the MK group, and the PK group, respectively. Compared with the control, none of the interventions significantly reduced the likelihood of POD occurrence.
This randomized controlled trial demonstrated the feasibility of recruiting and retaining surgical patients for a multi-arm perioperative intervention study. Although the interventions did not significantly reduce the incidence of POD, the study design and procedures were feasible, with acceptable recruitment and attrition rates. Compared to placebo, none of the interventions significantly reduced the incidence of POD; however, time was a significant factor, with POD incidence, severity, and pain decreasing longitudinally.
IR.TUMS.IKHC.REC.1401.374, registration date: 14 February 2023 and IRCT code: IRCT20120527009886N2, registration date: 07/03/2023.
本研究旨在探讨术前5毫克褪黑素和术中50毫克氯胺酮对预防结直肠癌手术患者术后谵妄（POD）的可行性及效果。
在这项随机对照试验中，纳入了择期结直肠癌手术候选成年患者（>18岁）。患者被随机分为四组：安慰剂/生理盐水组（PS）、褪黑素/生理盐水组（MS）、安慰剂/氯胺酮组（PK）和褪黑素/氯胺酮组（MK）。各小组在手术前一晚口服5毫克褪黑素或安慰剂，麻醉诱导后给予50毫克氯胺酮或生理盐水。分别通过重症监护病房意识模糊评估法（CAM-ICU）和视觉模拟量表（VAS）（每日两次）评估POD的发生情况和严重程度以及疼痛严重程度，直至术后第4天。
共招募了104例患者（51%为男性，平均年龄：56.29±12.65），每周招募率为4.7例患者，损耗率为13.3%。PS组、MS组、MK组和PK组的POD患病率分别为17.3%、22.23%、16.67%和16.67%。与对照组相比，没有任何一种干预措施能显著降低POD发生的可能性。
这项随机对照试验证明了招募和留住手术患者进行多臂围手术期干预研究的可行性。虽然干预措施没有显著降低POD的发生率，但研究设计和程序是可行的，招募率和损耗率均可接受。与安慰剂相比，没有任何一种干预措施能显著降低POD的发生率；然而，时间是一个重要因素，POD的发生率、严重程度和疼痛程度在纵向均有所下降。
IR.TUMS.IKHC.REC.1401.374，注册日期：2023年2月14日；IRCT代码：IRCT20120527009886N2，注册日期：2023年3月7日。
