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AbstractObjectivesTo evaluate the clinical effectiveness and safety of a perioperative algorithm for cardiac output-guided haemodynamic therapy in patients undergoing major gastrointestinal surgery.DesignMulticentre randomised controlled trial.SettingSurgical services of 55 hospitals worldwide.Participants2498 adults aged ≥65 years with an American Society of Anesthesiologists physical status classification of II or greater and undergoing major elective gastrointestinal surgery, recruited between January 2017 and September 2022.InterventionsParticipants were assigned to minimally invasive cardiac output-guided intravenous fluid therapy with low dose inotrope infusion during and four hours after surgery, or to usual care without cardiac output monitoring.Main outcome measuresThe primary outcome was postoperative infection within 30 days of randomisation. Safety outcomes were acute cardiac events within 24 hours and 30 days. Secondary outcomes were acute kidney injury within 30 days and mortality within 180 days.ResultsIn 2498 patients (mean age 74 (standard deviation 6) years, 57% women), the primary outcome occurred in 289/1247 (23.2%) intervention patients and 283/1247 (22.7%) usual care patients (adjusted odds ratio 1.03 (95% confidence interval 0.84 to 1.25); P=0.81). Acute cardiac events within 24 hours occurred in 38/1250 (3.0%) intervention patients and 21/1247 (1.7%) usual care patients (adjusted odds ratio 1.82 (1.06 to 3.13); P=0.03). This difference was primarily due to an increased incidence of arrhythmias among intervention patients. Acute cardiac events within 30 days occurred in 85/1249 (6.8%) intervention patients and 79/1247 (6.3%) usual care patients (adjusted odds ratio 1.06 (0.77 to 1.47); P=0.71). Other secondary outcomes did not differ.ConclusionsThis clinical effectiveness trial in patients undergoing major elective gastrointestinal surgery did not provide evidence that cardiac output-guided intravenous fluid therapy with low dose inotrope infusion could reduce the incidence of postoperative infections. The intervention was associated with an increased incidence of acute cardiac events within 24 hours, in particular tachyarrhythmias. Based on these findings, the routine use of this treatment approach in unselected patients is not recommended.Trial registrationISRCTN Registry ISRCTN39653756.

AbstractObjectiveTo assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.DesignProspective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.SettingMultidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.Participants441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial.InterventionsPreoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided.Main outcome measuresThe primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months.ResultsThe incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected.ConclusionIn a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.Trial registrationAustralian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

This study determined whether a one-hour music intervention while patients were in the post-anesthesia care unit (PACU) could improve postoperative recovery for female patients. Single-center, prospective, randomized controlled trial. Tertiary university hospital in China. 194 females aged 18–65 years scheduled for laparoscopic gynecological surgical procedures under general anesthesia. Patients were randomly assigned to receive therapist-selected music through earphones or wore earphones without listening to music. The primary outcome was State-Trait Anxiety Inventory (STAI; STAI-S and STAI-T subscales) scores. Secondary outcomes included post-operative quality recovery scale (PQRS) scores and other scales assessing pain and sleep quality, as well as serum glucose, lactate, and stress hormones levels, including adrenocorticotropic hormone (ACTH), cortical hormone releasing hormone (CRH), cortisol, and aldosterone. Results from 188 patients were analyzed. Participants in both music and control groups had decreased STAI-S scores on the first and second postoperative days. The music group had a greater reduction in STAI-S scores than the control group (P < 0.001). The music group also had reduced agitation, pain intensity, and reliance on analgesics, as well as improved sleep quality compared to the control group. The control group had higher ACTH levels (P = 0.03) and cortisol levels (P = 0.003) than the music group. CRH, aldosterone, blood glucose, and lactate concentrations did not significantly differ between groups. Music intervention in PACU for female patients undergoing elective laparoscopic gynecological surgery under general anesthesia helped alleviate postoperative anxiety and enhanced the quality of postoperative recovery. [Display omitted] •Studies on the effects of music intervention in PACU on postoperative recovery are rare.•One-hour music intervention in PACU alleviated patient postoperative discomfort.•One-hour music intervention in PACU could be applied to improve the postoperative recovery quality in female patients.

AbstractObjectivesTo investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.ResultsBetween May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval −0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.ConclusionsFor patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.Trial registrationISRCTN13911492.

Background The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions to reduce the incidence of wound complications, especially for incisional hernia. However, this is based on low-certainty evidence. We could not find any recommendations for skin closure. The wound closure technique is an important determinant of the risk of wound complications, and a comprehensive approach to prevent wound complications should be developed. Methods We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery. Discussion This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates. Trial registration UMIN-CTR UMIN000048442. Registered on 1 August 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205

Electroencephalogram oscillations during general anesthesia may change as a function of cognitive and physical health. This study aimed to characterize associations between anesthesia-induced oscillations and postoperative outcomes in cardiac surgery patients over 60 years. This was a prespecified secondary data analysis from the Minimizing Intensive Care Unit Dysfunction with Dexmedetomidine-induced Sleep (MINDDS) study. Participants were admitted from home for elective cardiac surgery with cardiopulmonary bypass. The primary outcome was postoperative delirium obtained using the Confusion Assessment Method. Secondary outcomes were non-home discharge and 30-day readmission. The exposure of interest was alpha power measured during the maintenance phase of isoflurane-general anesthesia. Confounding cognitive and physical health variables were collected. Of 394 participants in the MINDDS study, 302 had analyzable electroencephalograms. The incidence of postoperative delirium was 11.1 %. Odds of postoperative delirium decreased by 14 % for every decibel increase in alpha power (OR 0.86, 95 % CI: 0.78 to 0.95; P = 0.004). This finding was not significant in adjusted analysis (ORadj 0.92, 95 % CI: 0.81 to 1.03; P = 0.154). Non-home discharge setting findings were not associated with alpha power. The odds of 30-day readmission decreased by 20 % for every decibel increase in alpha power (ORadj 0.80, 95 % CI: 0.71 to 0.91; P < 0.001). Findings were conserved in exploratory and sensitivity analyses. In this study anesthesia-induced oscillations were associated with postoperative outcomes; however, these were not independently associated with delirium or discharge disposition after considering preoperative cognitive and physical health. These oscillations were robustly associated with 30-day readmission however, which may help anesthesiologists identify high-risk patients, offering benefits beyond the operating room. Clinical trial registration: Registration Number: NCT02856594 •Secondary analysis of 394 participants in the MINDDS Study.•Intraoperative alpha power varied with measures of preoperative cognitive and physical health.•Intraoperative alpha power also predicted postoperative delirium, 30-day readmission, but not non-home discharge.•On adjusted analysis, intraoperative alpha power robustly predicted non-home discharge.•Intraoperative EEG oscillations change as a function of cognitive and physical health and predict perioperative outcomes.

•Enhanced recovery after surgery (ERAS) is multimodal pathway that aims to optimize patient outcomes.•ERAS addresses pre-, peri-, and post-operative factors in elective spinal and peripheral nerve patients.•ERAS provides a platform to engage the multidisciplinary team associated with a patient’s surgical journey. Despite surgical, technological, medical, and anesthetic improvements, patient outcomes following elective neurosurgical procedures can be associated with high morbidity. Enhanced recovery after surgery (ERAS) protocols are multimodal care pathways designed to optimize patient outcomes by addressing pre-, peri-, and post-operative factors. Despite significant data suggesting improved patient outcomes with the adoption of these pathways, development and implementation has been limited in the neurosurgical population. This study protocol was designed to establish the feasibility of a randomized controlled trial to assess the efficacy of implementation of an ERAS protocol on the improvement of clinical and patient reported outcomes and patient satisfaction scores in an elective inpatient spine surgery population. Neurosurgical patients undergoing spinal surgery will be recruited and randomly allocated to one of two treatment arms: ERAS protocol (experimental group) or hospital standard (control group). The experimental group will undergo interventions at the pre-, peri-, and post-operative time points, which are exclusive to this group as compared to the hospital standard group. The present proposal aims to provide supporting data for the application of these specific ERAS components in the spine surgery population and provide rationale/justification of this type of care pathway. This study will help inform the design of a future multi-institutional, randomized controlled trial. of this study will guide further efforts to limit post-operative morbidity in patients undergoing elective spinal surgery and to highlight the impact of ERAS care pathways in improving patient reported outcomes and satisfaction.

To investigate the effect of low-doses esketamine on spinal anesthesia-induced hypotension in women with preoperative anxiety undergoing elective cesarean section, the randomized controlled trial enrolled 120 women aged 18–35 years who preoperative State-Trait Anxiety Inventory State scores > 40, conducted from September 2022 to August 2023 in Xuzhou Central Hospital, China. Women in the esketamine group received a single intravenous injection of 0.2 mg/kg esketamine after sensory block level achieved. The incidence of hypotension in the esketamine group was significantly lower than the control group at T2 (10% [6 of 60]; P < 0.001), T3 (5.0% [3 of 60]; P = 0.007) and T4(5.0% [3 of 60]; P = 0.004). Despite being higher in the esketamine group, the overall rates of hypertension (11.7% [7 of 60]; P = 0.186), tachycardia (23.3% [14 of 60]; P = 0.246), and bradycardia (0.0% [0 of 60]; P = 0.079) were no significantly difference between the two groups. STAI-S scores was significantly lower in the esketamine group (mean [SD] 37.52[7.14]) than in the control group (mean [SD] 41.03[9.66], P = 0.39) in postoperative day 1. Spinal anesthesia combined with intravenous low-doses esketamine infusion can significantly reduce the incidence of hypotension in women with preoperative anxiety undergoing elective cesarean section.

Postoperative delirium was reported to be associated with increased postoperative mortality after liver resection. Therefore, it is crucial to prevent postoperative delirium in such cases. Ramelteon, an agonist of melatonin receptor has been suggested to be useful for preventing delirium. The aim of this study was to examine whether ramelteon is effective at preventing delirium after elective liver resection. The cases of patients who underwent liver resection at Nara Medical University (Nara, Japan) between January 2014 and August 2018 were analyzed. During the period from January 2017 to August 2018, ramelteon was prospectively administered to patients who underwent liver resection [8 mg/day on the day before surgery and on postoperative days 1 to 3] (ramelteon group), whereas ramelteon was not administered during the period from January 2014 to December 2016 (control group). The perioperative outcomes of the two groups were compared. There were 120 patients in the ramelteon group and 186 patients in the control group. No significant intergroup differences in background factors, including age, gender, and preoperative serological laboratory data, were detected. The incidence of postoperative delirium was significantly lower in the ramelteon group (5.8% vs. 15.1%, P = 0.035). Multivariate analysis revealed that being aged ≥75 (P = 0.002), being male (P = 0.020), cardiovascular disease (P = 0.023), blood loss ≥1000ml (P = 0.001) and the absence of ramelteon treatment (P = 0.046) were independent risk factors for postoperative delirium. The administration of ramelteon might reduce the risk of postoperative delirium after elective liver resection.