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This study was carried on between February 2020 and July 2021 at the Department of Neurosurgery, Tangdu Hospital, Air Force Medical University (Xi’an, China) and was registered with the Chinese Clinical Trial Registry (ChiCTR2000029570). The randomized control trial was approved by the Institutional Human Research and Ethics Committee of Tangdu Hospital. All patients were provided with all the information concerning the study, including detailed explanations and written notifications. Informed and signed consent was obtained from all patients to participate and all patients with CEA were screened for eligibility. Patients that required emergency surgery, had serious consciousness and movement disorders before surgery, required emergency surgery pathologically, or who had other confounding factors that may affect postoperative recovery (such as paralysis, spinal deformity, autoimmune diseases, myocardial infarction, serious infection, liver or kidney dysfunction or serious psychological or mental diseases) were excluded.

A total of 74 patients who met the selection criteria were randomized into either an ERAS group or control group. The selection sequence was computer generated and the results were reviewed by a statistician, which ensured the objectivity and randomness of the experiment. First, 35 patients were placed in the control group and received routine perioperative care according to the practice mode of the institution. The remaining 39 patients were assigned to the ERAS group and received treatment according to new ERAS nutritional protocol described in this study. The researchers responsible for the follow-up visit and the surgeons were all masked to treatment assignment during the study phase of CEA. Through these measures, the study was not affected by subjective human factors.

The screening tool we used was nutritional risk screening 2002 (NRS 2002), which was proposed by European Society for Parenteral and Enteral Nutrition (ESPEN) guidelines on the basis of analysis of controlled clinical trials (14–16). A total score greater than 3 indicated that the patient was malnourished or at risk of nutrition and should avail of nutritional support. If the score was 0–3, patients only had a slight risk were excluded from the study. Their status was reviewed weekly and these patients were received no nutritional support.

The nutrition plan for this ERAS was designed for patients undergoing CEA, based on concepts from other established plans and drawing on extensive and current evidence-based support for perioperative nutritional interventions. We have studied traditional nutritional support programs and improved them according to the specific conditions of individual patient, and creatively proposed a new set of ERAS nutritional programs. Briefly, our protocol includes the following aspects: (1) preoperative management and assessment, which aimed at correcting malnutrition, improving nutritional status and optimizing body composition. A nutritional support working group was established to cooperate closely with clinicians and support staff from the ultrasound, anesthesiology, inpatient and surgical care, and nutritional services departments. Patients in the ERAS group abstained from solid food for 6 h before surgery, took no more than 400 ml of carbohydrates orally 2 h before surgery and had their fasting blood glucose and preoperative blood glucose monitored. Meanwhile, for malnourished patients, preoperative nutritional support was required. The preferred method was enteral nutrition (EN) support 7–10 days before surgery, usually with oral nutrition supplementation. However, if the patient had an intake disorder, tube feeding was required. (2) Intraoperative surgery and anesthesiology management, although not the key to the ERAS nutritional program, was a standard intraoperative measure and an important prerequisite for ERAS. Firstly, selected the appropriate surgical position and approach, and designed a reasonable surgical incision. Secondly, ropivacaine was given before surgery for subcutaneous local anesthesia (when the operation time > 3 h, anesthesia was given again), concomitantly, general anesthesia combined with regional nerve block anesthesia was selected, and the systemic application of opioids was reduced. Next, it was necessary to strictly control arterial blood pressure and maintain the stability of cerebral flow during the operation, and monitor end-tidal carbon dioxide to prevent hyperventilation. Finally, optimized the suture of the incision and avoided routine drain placement. (3) Postoperative nutritional support: patients in the ERAS group were given parenteral nutrition (PN) and EN support according to their own gastrointestinal conditions. The timing and dose of early postoperative eating or EN were determined according to the patient’s gastrointestinal function and tolerance. Liquid food was taken 6 h after the operation, after which the patients could be changed to semi-liquid food after the intestinal ventilation was restored, and the intake could then be gradually increased according to the tolerance of the gastrointestinal tract. During this period, the oral administration or tube feeding of EN solution, as the core of ERAS nutritional care, played an irreplaceable role in postoperative nutritional support. In particular, when the patient was not suitable to receive EN, nutrients were provided by continuous infusion through the peripheral intravenous route of PN. In cases where EN could not be initiated, PN was supplemented as soon as possible if the patient was at high nutritional risk (NRS score ≥ 5). Supplemental PN was administered if EN intake and protein levels remained below 60% of target after 7–10 days of EN treatment. In addition, blood glucose continued to be strictly monitored postoperatively to keep it within the ideal range of 7.77–9.99 mmol/L.

Correspondingly, the control group adopted the traditional regimen, fasting for 8 h before surgery, with no water intake for 4 h before surgery. A liquid diet was given 1 day after surgery, which gradually returned to normal. It should be noted that the measures presented above are only one part of the ERAS scheme and must be highly compatible with other steps of ERAS in order to achieve better clinical treatment effect (Figure 1).

Patients received conventional perioperative care in our unit. Preoperative care mainly included psychological care of patients, ward environmental protection, advice on smoking and alcohol cessation, application of preventive antibiotics and antithrombotic therapy, etc. Meanwhile, postoperative care, including monitoring of vital signs every 1–2 h, nebulization of the airway, sleep management and setting discharge criteria was also implemented. Patients were also advised to perform appropriate rehabilitation exercise, which was conducive to the patient’s positive mood and a more ideal prognosis.

After discharge, it was recommended that patients limit heavy physical activity and avoid strenuous exercise for 3 to 4 weeks. Also, patients were instructed to maintain emotional stability and avoid excessive tension, excitement, or mood swings. In addition, it was also essential to develop good living habits, such as quitting smoking and drinking, eating a reasonable diet, and resting frequently. In terms of nutrition, for most surgical patients, low-salt, low-fat and easily digestible food was recommended to maintain a balanced diet and satisfy the body’s needs for various nutrients. If the patient lose weight significantly after surgery, it was recommended to increase the intake of calories and protein to meet the needs of rehabilitation. In particular, oral nutritional supplements were an important component of post-discharge dietary plans for surgical patients. For severely malnourished patients and patients with long postoperative hospital stay or intensive care units stay, oral nutritional supplements were instructed to be used for 3 to 6 months after surgery. Nursing personnel instructed the patient to self-observe bleeding tendency and take medication as prescribed. Finally, the patients needed to actively cooperate with telephone follow-up and outpatient follow-up.

Preoperatively, demographic variables including age, sex, height, weight, body mass index, education level, occupational status, marital status, American Society of Anesthesiologists grade, and patient comorbidities (smoking, diabetes, hypertension, hypercholesterolemia, etc.) were recorded clinically. Biochemical and clinical parameters, including albumin, hemoglobin, liver and kidney function, and electrolytes, were also measured by preoperative venous blood collection. During the operation, blood glucose, blood pressure, pulse, oxygen saturation, central venous pressure, body temperature, end-tidal carbon dioxide, and respiratory rate were monitored. Postoperatively, peripheral fasting venous blood was extracted on the first and third postoperative days to determine biochemical and clinical parameters. Furthermore, the patients’ bowel movements were observed and recorded, as were other conditions during the nutritional support treatment. Clinical outcome variables comprised readmission, reoperation, postoperative surgical and non-surgical complications, as well as functional recovery [Karnofsky performance status (KPS)] at discharge and at 30-days follow-up. The primary endpoint was the postoperative length of stay (LOS), and the secondary endpoints included postoperative complications, postoperative quality-of-life (QoL), medical cost, readmission, and evaluation of patient satisfaction. At the same time, the symptoms of each group were observed during the treatment, and the prognosis was determined at the time of discharge (17, 18).

The data analysis was performed using the SPSS (Ver. 19, IBM Corp., Armonk, NY, United States). Descriptive statistics were used to define baseline characteristics. The Kolmogorov–Smirnov test was used to identify the normal distribution of the variables. Group differences with continuous data with normal distribution were statistically examined using the Student’s t-test, while data without normal distribution were analyzed using the Mann–Whitney U-test. Readmission, complications, and mortality were analyzed using the chi-square test (with/without Yates correction) or Fisher’s accurate test. The sample size was powered to be 58 patients in each group based on the hypothesis that the primary outcome (postoperative LOS) would be reduced by 25% with a power of 80% and significance of 5%. Assuming a maximal dropout rate of 20%, the final sample size was determined as 74 patients per arm. In turn, analysis was planned when the minimal number of the predefined sample size was met. The data were considered to be statistically significant if p < 0.05.

Between February 2020 and July 2021, a total of 112 patients from our hospital were enrolled in the present study. After exclusion, a total of 74 patients (35 in the control group and 39 in the ERAS group) were included in the analysis (Figure 2). The demographic and clinical characteristics (including sex, mean age, mean BMI, ASA grade, and marital status, etc.) of the two groups of patients were not significantly different (p > 0.05). Concomitant diseases such as cerebral infarction, sequelae of cerebral infarction, cardiac/hypertension, diabetes mellitus, hypercholesterolemia, liver/gallbladder, lung, and miscellaneous were equally distributed between the two groups. In terms of nutrition, most patients both groups had normal nutritional status. Both groups of patients underwent CEA by the same experienced surgical team, and all patients received the assigned intervention. Characteristics of patients are shown in Table 1.

The main surgical results were shown in Table 2. The differences in mean duration of surgery, cross-clamping time, carotid plaque size, blood transfusion, lateral location, and blood loss >300 ml between the two groups were not remarkable. The mean duration of surgery of the ERAS group was 150.08 ± 19.89 min and that of the control group was 149.11 ± 21.71 min (p = 0.843). For intraoperative monitoring of CEA patients, blood loss is an important indicator. There were 9 and 11 patients whose blood loss volume was over 300 ml in the ERAS group and control group, respectively (p = 0.419). Additionally, two patients in the ERAS group required blood transfusion (i.e., red blood cell and blood plasma transfusions) during the operation, while none of the patients in the control group required a transfusion.

Table 3 mainly described the changes in the content of various substances in the blood before and after surgery. There was no significant difference in the levels of various nutrients between the two groups before surgery. However, at postoperative day (POD) 1, there was a significant trend toward an increase of albumin, hemoglobin and calcium in the ERAS group compared with the control group (p < 0.001), which continued at POD 3 (p < 0.05). The overall pattern of creatinine and magnesium levels was similar in ERAS group, which increased at POD 1 and then decreased over the next couple of days. In the control group, creatine and magnesium was increased at POD 1 and decreased to the preoperative level at POD 3, while the contents of other substances were decreased at POD 1 and increased at POD 3.

Evaluation of LOS, cost, and postoperative recovery were shown in Table 4. The data showed that LOS was significantly lower in the ERAS group than in the control group (4.31 ± 0.98 days vs. 6.71 ± 2.09 days, p < 0.001). Additionally, there was also a significant difference in overall cost between the two groups (2.43 ± 0.18 10,000 yuan in the ERAS group vs. 2.57 ± 0.26 10,000 yuan in the control group, p < 0.05).

All patients completed the discharge satisfaction survey questionnaire. The figure below showed the changes and differences in QoL and Mini-mental State Examination (MMSE) scores between the two groups before surgery, at discharge, and at postoperative month (POM) 3 (Figure 3). The mean overall satisfaction of patients in the ERAS group at discharge was significantly higher than that of the control group (89.82 ± 3.52 score vs. 80.31 ± 4.04 score). Similarly, there were differences in satisfaction between the two groups, with obvious differences in medical care (18.46 ± 1.23 score in the ERAS group vs. 17.23 ± 1.82 score in the control group), nursing care (18.95 ± 1.07 score in the ERAS group vs. 17.49 ± 1.80 score in the control group), and enhanced recovery (18.26 ± 1.48 score in the ERAS group vs. 13.49 ± 2.85 score in the control group; p < 0.001).

There was little difference in QoL and MMSE scores between the two groups in preoperative period (p > 0.05), but differences were evident after discharge. At discharge, the QoL score of the ERAS group was 73.00 ± 3.93 score and that of the control group was 67.71 ± 5.20 score (p < 0.001). However, at POM 3, the QoL and MMSE scores of two groups showed no statistical difference (p > 0.05; Figure 3).

Follow-up results showed that survey satisfaction in the ERAS group was significantly higher than that in the control group (p < 0.001). There were significant differences in grip strength improvement at POM3 between the two groups (5.95 ± 2.08 score in the ERAS group vs. 4.54 ± 2.31 score in the control group, p = 0.007). However, no remarkable difference between the two groups was noted in the other outcomes relating to the KPS score (90.00 ± 3.83 score in the ERAS group vs. 89.95 ± 3.41 score in the control group, p = 0.952). Detailed patient satisfaction scores according to each module are shown in Table 4.

Table 5 showed the postoperative complications. Stroke, as an important complication after CEA, occurred in one patient (2.56%) in the ERAS group and two patients (5.71%) in the control group (p = 0.493). Two patients in the ERAS group and none in the control group had deep vein thrombosis (p = 0.130). None of the patients experienced symptoms of dyspnea or surgical site infection/subcutaneous effusion in the ERAS group. Additionally, postoperative nausea and vomiting intensity scale and nausea visual analog scale were performed postoperatively in both groups, but the proportions of patients with mild, moderate, and severe disease varied.