Paul S. Myles

Bispectral index monitoring to prevent awareness during anaesthesia: The b-aware randomised controlled trial

BACKGROUND Awareness is an uncommon complication of anaesthesia, affecting 0.1-0.2% of all surgical patients. Bispectral index (BIS) monitoring measures the depth of anaesthesia and facilitates anaesthetic titration. In this trial we determined whether BIS-guided anaesthesia reduced the incidence of awareness during surgery in adults. METHODS We did a prospective, randomised, double-blind, multicentre trial. Adult patients at high risk of awareness were randomly allocated to BIS-guided anaesthesia or routine care. Patients were assessed by a blinded observer for awareness at 2-6 h, 24-36 h, and 30 days after surgery. An independent committee, blinded to group identity, assessed every report of awareness. The primary outcome measure was confirmed awareness under anaesthesia at any time. FINDINGS Of 2463 eligible and consenting patients, 1225 were assigned to the BIS group and 1238 to the routine care group. There were two reports of awareness in the BIS-guided group and 11 reports in the routine care group (p=0.022). BIS-guided anaesthesia reduced the risk of awareness by 82% (95% CI 17-98%). INTERPRETATION BIS-guided anaesthesia reduces the risk of awareness in at-risk adult surgical patients undergoing relaxant general anaesthesia. With a cost of routine BIS monitoring at US16 dollars per use in Australia and a number needed to treat of 138, the cost of preventing one case of awareness in high-risk patients is about 2200 dollars.

Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial

BACKGROUND Epidural block is widely used to manage major abdominal surgery and postoperative analgesia, but its risks and benefits are uncertain. We compared adverse outcomes in high-risk patients managed for major surgery with epidural block or alternative analgesic regimens with general anaesthesia in a multicentre randomised trial. METHODS 915 patients undergoing major abdominal surgery with one of nine defined comorbid states to identify high-risk status were randomly assigned intraoperative epidural anaesthesia and postoperative epidural analgesia for 72 h with general anaesthesia (site of epidural selected to provide optimum block) or control. The primary endpoint was death at 30 days or major postsurgical morbidity. Analysis by intention to treat involved 447 patients assigned epidural and 441 control. FINDINGS 255 patients (57.1%) in the epidural group and 268 (60.7%) in the control group had at least one morbidity endpoint or died (p=0.29). Mortality at 30 days was low in both groups (epidural 23 [5.1%], control 19 [4.3%], p=0.67). Only one of eight categories of morbid endpoints in individual systems (respiratory failure) occurred less frequently in patients managed with epidural techniques (23% vs 30%, p=0.02). Postoperative epidural analgesia was associated with lower pain scores during the first 3 postoperative days. There were no major adverse consequences of epidural-catheter insertion. INTERPRETATION Most adverse morbid outcomes in high-risk patients undergoing major abdominal surgery are not reduced by use of combined epidural and general anaesthesia and postoperative epidural analgesia. However, the improvement in analgesia, reduction in respiratory failure, and the low risk of serious adverse consequences suggest that many high-risk patients undergoing major intra-abdominal surgery will receive substantial benefit from combined general and epidural anaesthesia intraoperatively with continuing postoperative epidural analgesia.

Society for Ambulatory Anesthesia Guidelines for the Management of Postoperative Nausea and Vomiting

The present guidelines were compiled by a multidisciplinary international panel of individuals with interest and expertise in postoperative nausea and vomiting (PONV) under the auspices of The Society of Ambulatory Anesthesia. The panel critically evaluated the current medical literature on PONV to provide an evidence-based reference tool for the management of adults and children who are undergoing surgery and are at increased risk for PONV. In brief, these guidelines identify risk factors for PONV in adults and children; recommend approaches for reducing baseline risks for PONV; identify the most effective antiemetic monotherapy and combination therapy regimens for PONV prophylaxis; recommend approaches for treatment of PONV when it occurs; and provide an algorithm for the management of individuals at increased risk for PONV.

Consensus Guidelines for the Management of Postoperative Nausea and Vomiting

The present guidelines are the most recent data on postoperative nausea and vomiting (PONV) and an update on the 2 previous sets of guidelines published in 2003 and 2007. These guidelines were compiled by a multidisciplinary international panel of individuals with interest and expertise in PONV under the auspices of the Society for Ambulatory Anesthesia. The panel members critically and systematically evaluated the current medical literature on PONV to provide an evidence-based reference tool for the management of adults and children who are undergoing surgery and are at increased risk for PONV. These guidelines identify patients at risk for PONV in adults and children; recommend approaches for reducing baseline risks for PONV; identify the most effective antiemetic single therapy and combination therapy regimens for PONV prophylaxis, including nonpharmacologic approaches; recommend strategies for treatment of PONV when it occurs; provide an algorithm for the management of individuals at increased risk for PONV as well as steps to ensure PONV prevention and treatment are implemented in the clinical setting.

Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial.

Background: Nitrous oxide is widely used in anesthesia, often administered at an inspired concentration around 70%. Although nitrous oxide interferes with vitamin B12, folate metabolism, and deoxyribonucleic acid synthesis and prevents the use of high inspired oxygen concentrations, the consequences of these effects are unclear. Methods: Patients having major surgery expected to last at least 2 h were randomly assigned to nitrous oxide–free (80% oxygen, 20% nitrogen) or nitrous oxide–based (70% N2O, 30% oxygen) anesthesia. Patients and observers were blind to group identity. The primary endpoint was duration of hospital stay. Secondary endpoints included duration of intensive care stay and postoperative complications; the latter included severe nausea and vomiting, and the following major complications: pneumonia, pneumothorax, pulmonary embolism, wound infection, myocardial infarction, venous thromboembolism, stroke, awareness, and death within 30 days of surgery. Results: Of 3,187 eligible patients, 2,050 consenting patients were recruited. Patients in the nitrous oxide–free group had significantly lower rates of major complications (odds ratio, 0.71; 95% confidence interval, 0.56–0.89; P = 0.003) and severe nausea and vomiting (odds ratio, 0.40; 95% confidence interval, 0.31–0.51; P < 0.001), but median duration of hospital stay did not differ substantially between groups (7.0 vs. 7.1 days; P = 0.06). Among patients admitted to the intensive care unit postoperatively, those in the nitrous oxide–free group were more likely to be discharged from the unit on any given day than those in the nitrous oxide group (hazard ratio, 1.35; 95% confidence interval, 1.05–1.73; P = 0.02). Conclusions: Avoidance of nitrous oxide and the concomitant increase in inspired oxygen concentration decreases the incidence of complications after major surgery, but does not significantly affect the duration of hospital stay. The routine use of nitrous oxide in patients undergoing major surgery should be questioned.

Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials

The relative analgesic efficacy and side-effect profile of peripheral nerve blockade (PNB) techniques compared with lumbar epidural analgesia for major knee surgery is unclear. We undertook a systematic review and meta-analysis of all randomized trials comparing epidural analgesia with PNB for major knee surgery. Eight studies were identified that had enrolled a total of 510 patients of whom 464 (91%) had undergone total knee joint replacement. All were small trials and none was blinded (Jadad score 1-3). PNB technique was variable: in addition to a femoral catheter (n=5), femoral single shot (n=2), or lumbar plexus catheter (n=1) techniques, sciatic blockade was performed in three trials. There was no significant difference in pain scores between epidural and PNB at 0-12 or 12-24 h, WMD 0.22 (95% CI: -0.36, 0.81), 0.05 (-1.01, 0.91), respectively, and no clinically significant difference at 24-48 h, WMD -0.35 (-0.64, -0.02). There was also no difference in morphine consumption (mg) at 0-24 h, WMD -6.25 (-18.35, 5.86). Hypotension occurred more frequently among patients who received epidurals [OR 0.19 (0.08, 0.45)], but there was no difference in the incidence of nausea and vomiting. Two studies reported a higher incidence of urinary retention in the epidural group. Patient satisfaction was higher with PNB in two of three studies which measured this, although rehabilitation indices were similar. PNB with a femoral nerve block provides postoperative analgesia which is comparable with that obtained with an epidural technique but with an improved side-effect profile and is less likely to cause a severe neuraxial complication.

Perioperative fluid management strategies in major surgery: a stratified meta-analysis

BACKGROUND: Both “liberal” and “goal-directed” (GD) therapy use a large amount of perioperative fluid, but they appear to have very different effects on perioperative outcomes. We sought to determine whether one fluid management strategy was superior to the others. METHODS: We selected randomized controlled trials (RCTs) on the use of GD or restrictive versus liberal fluid therapy (LVR) in major adult surgery from MEDLINE, EMBASE, PubMed (1951 to April 2011), and Cochrane controlled trials register without language restrictions. Indirect comparison between the GD and LVR strata was performed. RESULTS: A total of 3861 patients from 23 GD RCTs (median sample size = 90, interquartile range [IQR] 57 to 109) and 1160 patients from 12 LVR RCTs (median sample size = 80, IQR36 to 151) were considered. Both liberal and GD therapy used more fluid compared to their respective comparative arm, but their effects on outcomes were very different. Patients in the liberal group of the LVR stratum had a higher risk of pneumonia (risk ratio [RR] 2.2, 95% confidence interval [CI] 1.0 to 4.5), pulmonary edema (RR 3.8, 95% CI 1.1 to 13), and a longer hospital stay than those in the restrictive group (mean difference [MD] 2 days, 95% CI 0.5 to 3.4). Using GD therapy also resulted in a lower risk of pneumonia (RR 0.7, 95% CI 0.6 to 0.9) and renal complications (0.7, 95% CI 0.5 to 0.9), and a shorter length of hospital stay (MD 2 days, 95% CI 1 to 3) compared to not using GD therapy. Liberal fluid therapy was associated with an increased length of hospital stay (4 days, 95% CI 3.4 to 4.4), time to first bowel movement (2 days, 95% CI 1.3 to 2.3), and risk of pneumonia (RR ratio 3, 95% CI 1.8 to 4.8) compared to GD therapy. CONCLUSION: Perioperative outcomes favored a GD therapy rather than liberal fluid therapy without hemodynamic goals. Whether GD therapy is superior to a restrictive fluid strategy remains uncertain.

The Pain Visual Analog Scale: Is It Linear or Nonlinear?

UNLABELLED The visual analog scale (VAS) is a tool widely used to measure pain, yet controversy surrounds whether the VAS score is ratio or ordinal data. We studied 52 postoperative patients and measured their pain intensity using the VAS. We then asked them to consider different amounts of pain (conceptually twice as much and then half as much) and asked them to repeat their VAS rating after each consideration (VAS2 and VAS3, respectively). Patients with unrelieved pain had their pain treated with IV fentanyl and were then asked to rate their pain intensity when they considered they had half as much pain. We compared the baseline VAS (VAS1) with VAS2 and VAS3. The mean (95% confidence interval) for VAS2:1 was 2.12 (1.81-2.43) and VAS3:1 was 0.45 (0.38-0.52). We conclude that the VAS is linear for mild-to-moderate pain, and the VAS score can be treated as ratio data. IMPLICATIONS A change in the visual analog scale score represents a relative change in the magnitude of pain sensation. Use of the VAS in comparative analgesic trials can now meaningfully quantify differences in potency and efficacy.

Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial.

Objective To compare long term recurrence of cancer and survival of patients having major abdominal surgery for cancer. Design Long term follow-up of prospective randomised controlled clinical trial in which patients were randomly assigned to receive general anaesthesia with or without epidural block for at least three postoperative days. Setting 23 hospitals in Australia, New Zealand, and Asia. Participants 503 adult patients who had potentially curative surgery for cancer. Main outcome measure Cancer-free survival (analysis was by intention to treat). Results Long term follow-up data were available for 94% (n=446) of eligible participants. The median time to recurrence of cancer or death was 2.8 (95% confidence interval 0.7 to 8.7) years in the control group and 2.6 (0.7 to 8.7) years in the epidural group (P=0.61). Recurrence-free survival was similar in both epidural and control groups (hazard ratio 0.95, 95% confidence interval 0.76 to 1.17; P=0.61). Conclusion Use of epidural block in abdominal surgery for cancer is not associated with improved cancer-free survival. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000637448

Prehospital Rapid Sequence Intubation Improves Functional Outcome for Patients With Severe Traumatic Brain Injury: A Randomized Controlled Trial

Objective: To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital. Background: Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes. Methods: In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge. Results: A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1–6) in patients intubated by paramedics compared with 3 (interquartile range, 1–6) in the patients intubated at hospital (P = 0.28). The proportion of patients with favorable outcome (GOSe, 5–8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00–1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge. Conclusions: In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.