Is albumin administration beneficial in early stage of postoperative hypoalbuminemia following gastrointestinal surgery?: a prospective randomized controlled trial

Background

Surgeons commonly see postoperative hypoalbuminemia, but whether exogenous albumin administration is beneficial for these patients is unclear.

Methods

A prospective, randomized study design was used, allocating 127 hypoalbuminemic patients into the albumin or saline group after gastrointestinal surgery. We investigated the development of postoperative hypoalbuminemia, nutritional status, postoperative fluid balance, postoperative complications, and postoperative hospital stay.

Results

Plasma albumin concentrations of both groups decreased after operations (P <.01). No significant differences were found between groups (P >.05) in changes in postoperative plasma albumin concentration from baseline levels. Postoperative plasma albumin, total protein, and prealbumin levels were similar in the 2 groups. While 3-day and 5-day recovery ratios were similar, 7-day recovery ratios were lower in the albumin group (P <.05). No significant difference was found in overall fluid administration, urine output, or the incidence of postoperative complications between groups (23.4% for albumin group and 12.7% for control group, P = .116).

Conclusions

Albumin administration in the early stage of postoperative hypoalbuminemia following gastrointestinal surgery is not beneficial in correcting hypoalbuminemia or in clinical outcomes.     

Are postoperative intravenous fluids in patients undergoing elective laparoscopic cholecystectomy a necessity? A randomized clinical trial

Background

Intravenous (IV) fluid therapy should be individualized according to each patient's weight, disease, and comorbidities, as well as the type and duration of the operative procedure. Laparoscopic cholecystectomy represents one of the most common, short-duration operations; thus, the aim of this study was to assess the necessity of postoperative administration of IV fluids.

Safety of postoperative thromboprophylaxis after major hepatobiliary–pancreatic surgery in Japanese patients

Background and purpose

Thromboprophylaxis is recommended for preventing postoperative venous thromboembolism (VTE) after abdominal surgery; however, its use after major hepatobiliary–pancreatic surgery is typically avoided as it increases the risk of bleeding. We conducted this study to evaluate the safety of thromboprophylaxis after major hepatobiliary–pancreatic surgery.

Methods

We analyzed the rates of postoperative bleeding, VTE, morbidity, and prolonged hospital stay in 349 patients who underwent major hepatobiliary–pancreatic surgery, such as pancreaticoduodenectomy, hemihepatectomy or greater, and hepatopancreaticoduodenectomy.

Results

Chemical thromboprophylaxis was associated with significantly increased rates and risks of overall bleeding events vs. no chemical thromboprophylaxis (26.6 vs. 8.5 %, respectively). The rate of minor hemorrhage was significantly higher in patients who received chemical thromboprophylaxis (21.7 vs. 3.5 %); however, there were no differences in the rate of major hemorrhage requiring blood transfusion or hemostatic intervention between the groups (4.8 vs. 4.9 %). The postoperative VTE rate was also significantly decreased by chemical thromboprophylaxis (2.9 vs. 7.7 %). However, chemical thromboprophylaxis did not affect the rate of SSI, severe morbidity, or duration of the postoperative hospital stay.

Conclusion

We consider that chemical thromboprophylaxis is beneficial and can be safely used even after major hepatobiliary–pancreatic surgery.     

An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale—A randomized controlled trial

Study DesignA nonblinded randomized controlled trial.IntroductionOccupation-based interventions are superior to physical exercise–based interventions in patients with activity limitations. However, only a few studies have examined the effect in patients with hand-related disorders. Patients recover heterogeneously, which could be due to personal factors, such as sense of coherence (SOC).Purpose of the studyTo investigate the effectiveness of an occupation-based intervention for patients with hand-related disorders and whether SOC can give an indication of the expected effects.MethodsA total of 504 patients were stratified into three SOC groups and then randomized to either an occupation-based intervention, including physical exercises (OBI) or a physical exercise–based occupation-focused intervention. The primary outcome, functioning, was measured using the Disability of the Arm, Shoulder and Hand questionnaire. Primary endpoint was at three months. Patients were followed up for a year.ResultsNo significant difference was found in primary outcome analysis. Nevertheless, patients receiving OBI had a statistically significant and greater change in satisfaction with their occupational performance at one, two, and three months follow-up. Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.ConclusionsOBI as delivered in this study was not superior to physical exercise–based occupation-focused intervention in this patient group. However, in taking a client-centered approach, we recommend that OBI be based on individual needs, given that patients had a statistically greater change in score regarding satisfaction with their occupational performance. It is evident that patients with a weaker SOC have a lower level of functioning. This knowledge should inform clinical practice.     

Do off-pump techniques reduce the incidence of postoperative atrial fibrillation in elderly patients undergoing coronary artery bypass grafting?

BACKGROUND: Atrial fibrillation is the most common postoperative complication in patients undergoing coronary artery bypass grafting (CABG) with advancing age having been shown to have a significant association with its incidence. This study aims to assess whether off-pump coronary artery bypass (OPCAB) reduces the incidence of atrial fibrillation in elderly patients. METHODS: A meta-analysis of all observational studies reporting a comparison between the two techniques in elderly patients (> 70 years) between 1999-2003 was performed. The primary outcome of interest was the incidence of postoperative atrial fibrillation. The quality of each study was evaluated by examining three items: patient selection, matching of the off-pump and cardiopulmonary bypass patient groups, and assessment of outcome. Meta-regression analysis was undertaken to see the effects of study size and quality on the calculated odds ratio. RESULTS: Eight studies fulfilled our inclusion criteria, all of which were nonrandomized. In total the studies identified 3017 subjects, of which 764 had off-pump surgery (25%) and 2253 underwent cardiopulmonary bypass (75%). Meta-analysis showed that after off-pump surgery there was a significantly lower incidence of postoperative atrial fibrillation in these patients (odds ratio 0.70, 95% confidence interval [CI] 0.56-0.89). Meta-regression analysis including study characteristics did not show any associations affecting the calculated odds ratio of atrial fibrillation. CONCLUSIONS: Our study demonstrates a reduced incidence of postoperative atrial fibrillation in an elderly population with off-pump as compared with cardiopulmonary bypass techniques. We appreciate, however, that our statistical analysis uses nonrandomized published data and that the results must be treated with caution. If this finding is confirmed by a large-scale randomized trial, it has significant implications on the operative strategy employed for this patient group.     

The Flex-Tip™ tracheal tube does not reduce the incidence of postoperative sore throat: a randomized controlled trial

Purpose

Sore throat after tracheal intubation is common with an incidence of 30-70%. The Parker Flex-Tip? endotracheal tube (ETT) is designed to reduce trauma during ETT placement. This randomized single-blinded trial was designed to assess whether using the Flex-Tip ETT would reduce the incidence of postoperative sore throat and/or vocal change.

Methods

A Flex-Tip or a Mallinckrodt Hi–Lo® cuffed ETT was used by random allocation in 200 patients with normal-appearing airways requiring elective orotracheal intubation. On the second postoperative day, a blinded assessor recorded the incidence and severity of postoperative sore throat and voice alteration. The primary outcome was the incidence of moderate or severe sore throat. Secondary outcomes included vocal change, time to intubation, number of attempts/failures, incidence of oropharyngeal bleeding, and subjective ease of intubation.

Results

Demographic data were similar between the two groups. Moderate or severe sore throat was observed in 12% of patients with the Flex-Tip ETT and 6% of patients with the Mallinckrodt Hi–Lo ETT (odds ratio [OR] 2.1; 95% confidence intervals [CI] 0.70 to 7.1; P = 0.14). The incidence of moderate or severe vocal change was 6% and 3%, respectively (OR 2.0; 95% CI 0.42 to 12.9; P = 0.50). Time to intubation, number of intubation attempts, incidence of oropharyngeal bleeding, and ease of intubation did not differ significantly between groups.

Conclusion

In this study involving experienced clinicians, no significant difference was observed in the incidence of postoperative sore throat or vocal change between the Flex-Tip ETT and the standard Mallinckrodt Hi-Lo cuffed ETT. This trial was registered at www.clinicaltrials.gov, NCT01095861.     

Postoperative continuous-flow cryocompression therapy in the acute recovery phase of hip fracture surgery—A randomized controlled clinical trial

BackgroundThe acute recovery phase after hip fracture surgery is often complicated by severe pain, postoperative blood loss with subsequent transfusion, and delirium. Prevalent comorbidity in hip fracture patients limit the use of opioid-based analgesic therapies, yielding a high risk for inferior pain treatment. Postoperative cryotherapy is suggested to provide an analgesic effect, and to reduce postoperative blood loss. In this prospective, open-label, parallel, multicentre, randomized controlled, clinical trial, we aimed to determine the efficacy of continuous-flow cryocompression therapy (CFCT) in the acute recovery phase after hip fracture surgery.MethodsPatients with an intra or extracapsular hip fracture scheduled for surgery were included. Subjects were allocated to receive postoperative CFCT or usual care. The primary endpoint was numeric rating scale (NRS) pain the first 72 postoperative hours. Secondly, analgesic use; postoperative haemoglobin change and transfusion incidence; functional outcome; length of stay; delirium incidence; location of rehabilitation; patient-reported health outcome; complications and feasibility were assessed.ResultsSixty-one subjects in the control group, and 64 subjects in the CFCT group were analysed. Within the CFCT group, post treatment NRS pain declined 0.31 (p = 0.07) at 24 h, 0.28 (p = 0.07) at 48 h, and 0.47 (p = 0.002) at 72 h relative to pre treatment NRS pain. Sensitivity analysis at 72 h showed that NRS pain was 0.92 lower in the CFCT group when compared to the control group (1.50 vs. 2.42; p = 0.03). Postoperative analgesic use was comparable between groups. Between postoperative day one and three haemoglobin declined 0.29 mmol/l in the CFCT group and 0.51 mmol/l in controls (p = 0.06), and transfusion incidence was comparable. The timed up and go test and length of stay were also comparable between both groups. Complications, amongst delirium and cryotherapy-related adverse events were not statistically significantly different. Discharge locations did not differ between groups. At outpatient follow-up subjects did not differ in patient-reported health outcome scores. Subjects rated CFCT satisfaction with an average of 7.1 out of 10 points.ConclusionsNo evidence was recorded to suggest that CFCT has an added value in the acute recovery phase after hip fracture surgery. If patients complete the CFCT treatment schedule, a mild analgesic effect is observed at 72 h.     

An individualised tapering protocol reduces opioid use 1 year after spine surgery: A randomised controlled trial of patients with preoperative opioid use

Background

Persistent opioid use following surgery is common especially in patients with preoperative opioid use. This study aims to determine the long-term effect of an individualised opioid tapering plan versus standard of care in patients with a preoperative opioid use undergoing spine surgery at Aarhus University Hospital, Denmark.

Methods

This is the 1-year follow-up of a prospective, single-centre, randomised trial of 110 patients who underwent elective spine surgery for degenerative disease. The intervention was an individualised tapering plan at discharge and telephone counselling 1 week after discharge, compared to standard of care. Postoperative outcomes after 1 year include opioid use, reasons for opioid use and pain intensity.

Results

The overall response rate to the 1-year follow-up questionnaire was 94% (intervention group 52/55 patients and control group 51/55 patients). Forty-two patients (proportion = 0.81, 95% CI 0.67–0.89) in the intervention group compared to 31 (0.61, 95% CI 0.47–0.73; p = .026) patients in the control group succeeded in tapering to zero 1 year after discharge (p = .026). One patient (0.02, 95% CI 0.01–0.13) in the intervention group compared to seven patients (0.14, 95% CI 0.07–0.26) in the control group were unable to taper to their preoperative dose 1 year after discharge (p = .025). Back/neck and radicular pain intensity was similar between study groups.

Conclusion

These results suggest that an individualised tapering plan at discharge combined with telephone counselling 1 week after discharge can reduce opioid use 1 year after spine surgery.     

Effects of intravenous adenosine 5′-triphosphate on intraoperative hemodynamics and postoperative pain in patients undergoing major orofacial surgery: a double-blind placebo-controlled study

Purpose  We conducted a double-blind placebo-controlled study to investigate the effects of the intraoperative intravenous infusion of adenosine 5′-triphosphate (ATP) on intraoperative hemodynamics and postoperative pain in patients undergoing major orofacial surgery. Methods  Thirty patients (age, 16–42 years; 16 males/14 females) scheduled for sagittal split ramus osteotomy were assigned in a double-blind fashion to receive intraoperative intravenous infusion of ATP (n = 15) or saline (n = 15). Anesthesia was induced and maintained with propofol, fentanyl, and vecuronium. Local anesthesia was added for intraoperative analgesia. In the ATP group, ATP was infused at a rate of 160 μg·kg⁻¹·min⁻¹ throughout surgery. Postoperative pain was managed with intravenous patient-controlled analgesia (PCA) with morphine. The intensity of postoperative pain was assessed with a verbal numeric rating scale (NRS). Morphine consumption was also assessed. Results  There were no differences in demographic, anesthetic, and surgical data between the ATP and placebo groups. Intraoperatively, ATP effectively suppressed responses of blood pressure and heart rate to painful surgical stimuli. There were no differences in postoperative NRS scores between the two groups. However, postoperative morphine consumption was significantly less in the ATP group, compared with the placebo group, throughout the 72-h postoperative observation period. Cumulative morphine consumption for 72 h postoperatively was 47% less with ATP, compared with placebo. No adverse effect of ATP was observed. Conclusion  Our data suggest that intraoperative ATP infusion can blunt hemodynamic responses to surgical stimuli and produce prolonged analgesia in patients undergoing major orofacial surgery.     

“Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption,postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlled trial”

Study objectiveThe Nociception Level (NOL) index uses a multiparametric approach to measure the balance between sympathetic and parasympathetic systems activity. Recently, a strong correlation between the NOL index response to nociceptive stimuli and the level of opioid analgesia during surgery was reported. Others observed that intraoperative doses of remifentanil and sufentanil were reduced when the NOL index was used. So far, no study has evaluated the impact of NOL-guided fentanyl antinociception in laparoscopic gynecological surgery. The primary hypothesis of this present study was to evaluate whether intraoperative NOL-guided fentanyl administration would reduce intra-operative opioid consumption. Secondary hypotheses were to assess whether this would lead to lower postoperative opioid consumption and pain scores, as well as improved postoperative outcomes.SettingUniversity hospital, operating room.Patients70 adult patients, ASA 1–3, scheduled for total laparoscopic hysterectomy.InterventionsPatients were randomized into 2 groups: SOC (standardization of care) and NOL (using the NOL index to guide the administration of fentanyl). The depth of anesthesia was monitored with BIS™. Intraoperative fentanyl boluses were administered based on heart rate and mean arterial pressure variations in the SOC group, and NOL index for the NOL group.MeasurementsFentanyl total intraoperative dose administered was collected and also averaged per hour. Pain scores and hydromorphone consumption were assessed in the post-anesthesia care unit and up to 24 h.Main resultsSixty-six patients completed the study, 33 in each group. Total intraoperative fentanyl administration was not different between the two groups (217 (70) in the NOL group vs 280 (210) in the SOC group (P = 0.11)). Nevertheless, intraoperative fentanyl administration per hour was reduced by 25% in the NOL-guided group compared to the SOC group: 81 (24) vs 108 (66) μg.h⁻¹, respectively (P = 0.03). Hydromorphone consumption and pain scores in the post-anesthesia care unit and at 24 h were not significantly different between the two groups.ConclusionNOL-guided analgesia allowed for a 22% reduction of the total amount of intraoperative fentanyl which was not significant. Nevertheless, results reported a significant reduction by 25% in the doses of fentanyl averaged per hour of surgery and administered in the NOL-guided group compared with the standardized practice in laparoscopic gynecological surgery. The pain measured postoperatively was similar in the two groups while the average postoperative consumption of opioids to achieve the same level of pain scores in post-anesthesia care unit and at 24 h was not significantly reduced. Further larger multicenter studies centered towards postoperative outcomes are needed.     

Endothelial dysfunction in geriatric diabetic patients: the role of microalbuminuria in elderly type 2 diabetic patients? A randomized controlled study

Backgrounds/Aims Microalbuminuria is considered a marker of extensive endothelial dysfunction and is associated with excess of other cardiovascular risk factors. Our aim is to assess the importance of the presence of microalbuminuria in elderly diabetic patients. Methods A total of 40 normotensive elderly type 2 diabetic patients of both genders with mean age >65 years were randomly included and were further subdivided according to the presence of persistent microalbuminuria into microalbuminuric and normoalbuminuric groups. Patients and methods All patients in both groups were subjected to thorough clinical and laboratory investigations including the assay of serum thrombomodulin (TM) and glycosylated hemoglobin level. Early-morning midstream urine samples were evaluated for levels of beta 2 microglobulin, alpha 1 microglobulin, TM, and N-acetyl-beta-d-glucosaminidase (NAG). Results There was no significant difference between both groups regarding the clinical demographic characteristics. There were statistically significant higher values for glycosylated hemoglobin percentage, serum triglycerides and serum TM and urinary B2 microglobulin, urinary alpha 1 microglobulin, urinary NAG and urinary thrombomodulin in microalbuminuric group in comparison to normoalbuminuric group (P < 0.05). Conclusion Microalbuminuria is associated with markers of endothelial dysfunction in elderly normotensive type 2 diabetic patients. We recommend incorporation of periodic testing for microalbuminuria in this sector of patients     

Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

Background

The aim of this study was to evaluate postoperative complications in patients having major elective surgery using oesophageal Doppler monitor-guided goal-directed haemodynamic therapy (GDHT), in which administration of fluids, inotropes, and vasopressors was guided by stroke volume, mean arterial pressure, and cardiac index.

Incidence of complications in the post-anesthesia care unit and associated healthcare utilization in patients undergoing non-cardiac surgery requiring neuromuscular blockade 2005–2013: A single center study

Study objectiveThe use of neuromuscular blockade agents (NMBA), had been associated with significant residual post-operative paralysis and morbidity. There is a lack of clinical evidence on incidence of postoperative complications within the post-anesthesia care unit (PACU) in patients exposed to intraoperative NMBA's. This study aims to estimate the incidence of post-operative complications associated with use of NMBAs and assessing its association with healthcare resource utilization.DesignRetrospective cohort.SettingPost-anesthesia care unit in tertiary care center.PatientsAdults having non-cardiac surgery and receiving NMBAs between April-2005 and December-2013MeasurementsWe assessed: 1) incidences of major and minor PACU complications, 2) incidence of any postoperative complication in patients receiving a NMBA reversal (neostigmine) vs. without. 3) We secondarily assessed the relationship between PACU complications and use of healthcare resources.Main resultsThe incidence of any major complications was 2.1% and that of any minor complication was 35.2%. ICU admission rate was 1.3% in patients without any complications, versus 5.2% in patients with any minor and 30.6% in patients with any major complication. ICU length of stay was prolonged in patients with any major (52.1 ± 203 h), compared to patients with any minor (6.2 ± 64 h) and with no complications (1.7 ± 28 h). Patients who received a NMBA and neostigmine, compared to without neostigmine, had a lower incidence of any major complication (1.7% vs. 6.05%), rate of re-intubation (0.8% vs. 4.6%) and unplanned ICU admission (0.8% vs. 3.2%).ConclusionsThis study documents that incidence of major PACU complications after non-cardiac surgery was 2.1%, with the most frequent complications being re-intubation and ICU admission. Patients receiving NMBA reversal were at a lower risk of re-intubation and unplanned ICU admission, justifying routine use of reversals. Complete NMBA reversals are crucial in reducing preventable patient harm and healthcare utilization.