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

A reduction in symptoms, increased longevity, and improved quality of life (QoL), are goals of cardiac surgery. We measured QoL in 108 adult cardiac surgical patients at about three years after cardiac surgery, and assessed the predictive ability of a 40-item quality of recovery (QoR-40) score. Our follow-up rate was 86% (n=93). When compared with preoperative status, QoL was improved at three years after surgery (P<0.0005). The dimensions of QoL that were most affected were physical functioning, role limitations due to physical problems, vitality, social functioning, and role limitations due to emotional problems (all P<0.005). There was a mild correlation between the day 3 QoR-40 and the three year SF-36, r=0.23 (P=0.029). There was a strong correlation between the three year QoR-40 and the three year SF-36, r=0.73 (P<0.0005). The QoR-40 and SF-36 done at three years after cardiac surgery demonstrated good internal consistency, QoR-40 α=0.86 (P<0.0005), SF-36 α=0.91 (P<0.0005). A poor quality recovery in the days after surgery can predict a poor QoL at three years after surgery. The QoR-40 is a valid and reliable measure of quality of recovery after surgery and anaesthesia. The QoR-40 is a useful, patient-oriented method of assessing recovery from anaesthesia and surgery.

A 40-item questionnaire (the QoR-40) had been previously developed to measure five dimensions of quality of recovery after anaesthesia and surgery. Each of the 40 items is rated on a scale of 1 to 5, with a maximum score of 200. In this study we compared patient self-administered with investigator-administered QoR-40. We studied 62 postoperative patients within 48 hours of their surgery. Agreement between the two methods was analysed using the intraclass correlation coefficient, bias and limits of agreement. There was strong correlation between the investigator-administered and patient self-administered QoR-40 scores, intraclass correlation coefficient 0.86 (95% CI: 0.77 to 0.92), P<0.001. The bias and limits of agreement were 3.1 and -22 to 28, respectively. There were 10 (16%) patient self-administered questionnaires that were not completed at first attempt. The time to complete the questionnaire when investigator-administered was 253 (16) s [mean,(SD)], and on first attempt for patients was 362 (19) s, P<0.001. The QoR-40 is as valid measure of postoperative recovery when administered with the assistance of an investigator as compared with the patient self-administered version. Investigator-administered measurement of the QoR-40 is a more efficient use of resources, as complete and more timely data are collected.

BACKGROUND:Smoking is considered to be a risk factor for patients undergoing surgery and anesthesia, but it is unclear whether this is applicable to patients undergoing ambulatory surgery. The aim of this study was to determine the risk of respiratory complications and wound infection among smokers.METHODS:The authors studied a random selection of 489 adult patients undergoing ambulatory surgery. Smoking status was determined by self-report and confirmed with end-expired carbon monoxide analysis. The risk of respiratory complications (i.e., desaturation, cough, laryngospasm, bronchospasm, breath-holding, or apnea) and wound infection (i.e., wound redness or discharge +/- positive microbial culture, requiring antibiotic therapy) in smokers nonsmokers was ascertained. Odds ratios were estimated from multivariable logistic regression and adjusted for age, gender, body mass index, partner's smoking status, domiciliary smoking exposure, and extent and duration of surgery.RESULTS:Most smokers continued to smoke up until the day of surgery. Smokers had a higher rate of respiratory complications (32.8% vs. 25.9%; adjusted odds ratio, 1.71; 95% confidence interval, 1.03-2.84; = 0.038) and wound infection (3.6% vs. 0.6%; odds ratio, 16.3; 95% confidence interval, 1.58-175; = 0.019). Odds ratios comparing current plus ex-smokers with nonsmokers were of similar magnitude for most of these complications.CONCLUSIONS:Smoking was associated with an increased risk of respiratory complications and postoperative wound infection in ambulatory surgery patients. These findings warrant increased efforts at promoting smoking avoidance and cessation.

UNLABELLED:Remifentanil may be beneficial in patients undergoing coronary artery bypass graft surgery, by promoting hemodynamic stability, reducing drug requirements, and attenuating the neurohumoral "stress response." We enrolled 77 cardiac surgical patients in a double-blinded, randomized trial and randomly allocated them to one of three groups: remifentanil infusion at 0.83 micro g. kg(-1). min(-1) (Group R); fentanyl bolus, small dose, at 12 micro g/kg (Group FLD); and fentanyl bolus, moderate dose, at 24 micro g/kg (Group FMD). We found a significant difference in the median time to tracheal extubation: Group FLD, 6.5 h; Group R, 7.3 h; and Group FMD, 9.7 h (P = 0.025). Group R patients had similar times to those of Groups FLD (P = 0.14) and FMD (P = 0.30). Group FLD patients had a longer length of hospital stay (P = 0.030). Patients in Group R had a significantly infrequent rate of hypertension but a frequent rate of hypotension (P < 0.01). The urinary cortisol excretion was larger in Group FLD patients (P < 0.0005), and urine flow was smaller (P < 0.0005). Remifentanil was associated with a propofol dose reduction (P = 0.0005) and a concomitant higher bispectral index (P = 0.032). Three Group FLD patients, but none in groups FMD and R, had postoperative myocardial infarctions (P = 0.032). Remifentanil has larger drug acquisition costs but does not increase the total hospital costs associated with cardiac surgery. IMPLICATIONS:Remifentanil did not significantly reduce the duration of tracheal intubation after cardiac surgery. Remifentanil, when compared with fentanyl (total doses of approximately 15 and 28 micro g/kg), blunts the hypertensive responses associated with cardiac surgery but is associated with more hypotension; when compared with fentanyl 15 micro g/kg, remifentanil reduces cortisol excretion. Larger-dose opioids (remifentanil 0.85 micro g. kg(-1). min(-1) or fentanyl 28 micro g/kg) were associated with a decreased rate of myocardial infarction after cardiac surgery.

In this double-blinded, randomized controlled trial we tested if the addition of ketamine to morphine for patient-controlled analgesia (PCA) resulted in improved analgesic efficacy and lower pain scores compared with morphine PCA alone after major abdominal surgery. Seventy-one patients were ran-domly allocated to receive either morphine 1 mg/mL (Group M) or morphine 1 mg/mL plus ketamine 1 mg/mL (Group MK) delivered via PCA after surgery. No other analgesics or regional blocks were permitted during the 48-h study period. Postoperatively there were no differences between the groups for subjective assessment of analgesic efficacy, pain scores at rest, and on movement, opioid consumption, or adverse events. Group MK patients performed worse in cognitive testing (P = 0.037). There was an increased risk of vivid dreaming in patients who received ketamine (relative risk = 1.8, 95% confidence interval 0.78–4.3). We conclude that small-dose ketamine combined with PCA morphine provides no benefit to patients undergoing major abdominal surgery.

Background Improved quality of life (QoL) is a desirable outcome of cardiac surgery. The aim of the current study was to measure the association between quality of recovery 3 days after surgery and QoL measured 3 months later. Methods After obtaining ethics committee approval and consent, 120 adult cardiac surgical patients were studied. A 40-item quality of recovery score (QoR-40) was used to measure postoperative health status on days 1-3 and 1 month after surgery. QoL was measured using the short-form health survey (SF-36) at 1 and 3 months after surgery. The effect size (delta mean/SD) was used to define responsiveness, a clinically important difference in health. Associations were measured using correlation and reliability coefficients. Results There was a significant change in the mean QoR-40 for up to 1 month after surgery (P < 0.0005). QoL was improved at 3 months (P < 0.0005) but not 1 month (P = 0.29) after surgery. There was a moderate correlation between day-3 QoR-40 and 3-month SF-36 (r = 0.39; P < 0.0005). A poor-quality recovery in hospital predicted a poor QoL at 3 months (adjusted odds ratio, 4.20; 95% confidence interval, 1.41-12.5; P = 0.01). Conclusions The QoR-40 is a valid measure of quality of recovery after surgery and anesthesia. When compared with the SF-36, it is a better measure of early postoperative recovery. A poor-quality recovery on the days after surgery can predict a poor QoL at 3 months after surgery. This may allow earlier and more effective support strategies while patients are still in the hospital (counseling, home assistance, local doctor notification, cardiac rehabilitation).

Recent evidence shows that postoperative recovery may differ between men and women. 1 2 We planned a prospective cohort study to examine the impact of gender on postoperative outcome.This was associated with a trial investigating the effectiveness of several anaesthetic regimens.

To the Editor: Hogue et al. (1) report preliminary results of a questionnaire designed to assess functional status 24 h after outpatient surgery. They concluded that their questionnaire was a valid measure of final recovery and patient satisfaction. We were disappointed that they chose not to consider previous research addressing the same topic (2–5). Their findings were not, then, placed within the context of current knowledge or clinical practice. We have previously reported our experience of development and validation of two scoring systems that measure quality of recovery (4,5) after anesthesia and surgery. The QoR Score is a nine-item questionnaire that is simple to use in daily practice and suitable for quality assurance activities and audit (4). Its clinical utility in routine practice has been recently reported (6). The QoR-40 is a 40-item questionnaire with greater precision (4) and is more suited as a measure of outcome in clinical trials or for evaluation of specific changes in health care delivery. Validated scoring systems allow quantification of a patient’s early postoperative health status, which, in effect, is a description of their quality of recovery. How can we know which, if any, of the currently proposed instruments (1–5) should be preferentially chosen to measure the health status of patients in the period after anesthesia and surgery? How do each of them relate to eventual health status (quality of life)? These are important questions and are best answered by others, in other institutions. It is only then that we can be confident that we have an externally validated instrument that others can rely upon. We commend Hogue et al. for their work. It is now up to others to determine the relative merits of the currently available health status instruments that have been developed to measure aspects of a patient’s recovery after anesthesia and surgery. Such an evaluation should include comparative psychometric properties (validity, reliability, predictive ability) and their clinical utility (ease of use, time required for completion, personnel required). Paul S. Myles MB.BS, MPH, MD, FCARCSI, FANZCA Jennifer O. Hunt RN Helen Fletcher RN

OBJECTIVE The primary purpose of this study was to assess the relationship between preoperative risk factors, postoperative chronic pain, sleep, and gender on perceptions of quality of life (QoL) in a sample of 123 coronary artery bypass graft (CABG) surgery patients 12 months after surgery. A secondary purpose was to determine whether there is concordance between spousal and patient reporting of QoL after CABG surgery. DESIGN A cross-sectional comparative study. SETTING The study setting included patients living in the community, who had had CABG surgery 12 months earlier at The Alfred hospital, a major metropolitan public acute care center, in Melbourne, Australia. PARTICIPANTS Study participants were 123 adult patients (mean age = 64 years) who had undergone CABG surgery and had participated in a recent clinical trial. These patients were followed up to 12 months. The patient's spouse or next of kin (NoK) was asked questions about their perception of change in the patient's QoL. INSTRUMENTS Results were assessed using The Medical Outcome Study Short Form-36 (SF-36) questionnaire and additional questions given at 12 months after CABG surgery. The Cleveland Clinic Clinical Severity Score (CSS) was used preoperatively as a tool to predict QoL outcome. RESULTS Significant improvements in QoL, as measured by the SF-36, were seen in physical functioning (P <.0001), bodily pain (P =.024), social functioning (P =.011), and role limitations resulting from emotional status (P =.003). Other significant associations (P =.002) were found between poor QoL and patients who reported severe pain or poor quality sleep. Low-risk patients, as identified by the preoperative CSS, were more likely to have improved QoL at 12 months. Alteration in QoL was reported equally by patients and their spouses or NoK. Short-term memory impairment was reported by 41% of spouses or NoK. CONCLUSIONS CABG surgery results in improved QoL for the majority of patients with extensive coronary artery disease. Nevertheless, some patients continue to have severe pain, sleep disturbances, and altered relationship with their spouse or NoK 12 months after surgery.

When compared with thiopental and isoflurane, propofol and sevoflurane are associated with a faster return to wakefulness after anesthesia. Yet their wider usage in inpatient surgery has been restrained by concerns regarding their acquisition costs and by lack of studies demonstrating improved patient outcome. We randomly allocated 453 adult surgical inpatients to one of four anesthetic regimens (thiopental-isoflurane, propofol-isoflurane, propofol induction and maintenance, or sevoflurane induction and maintenance) and measured their rate and quality of recovery. We found no significant differences in the rate and quality of recovery between groups. Propofol was associated with more pain on injection (P < 0.0005), but less cough during induction (P = 0.003), and less early postoperative nausea and vomiting (P = 0.003). We could not detect any significant advantages with propofol and sevoflurane, when compared with thiopental and isoflurane in adults undergoing elective inpatient surgery. Implications Propofol and sevoflurane do not offer any significant advantages over thiopental and isoflurane in adults undergoing elective inpatient surgery.

Clonidine may have beneficial effects in patients undergoing major surgery. We enrolled 156 patients having elective CABG surgery in a double-blind, randomized trial. Patients were randomized to receive either two doses of placebo (Group PP) or clonidine 5 micrograms/kg (Group CC). Perioperative measurements included haemodynamics, anaesthetic and analgesic drug usage, creatinine clearance, cortisol excretion, recovery times and quality of life (SF-36) after surgery. Overall, there was no significant difference with time to tracheal extubation (median [10-90 centile]): CC 7.1 (3.4-18) h vs PP 8.0 (4.3-17) h, P = 0.70; but there was a higher proportion of patients extubated within four hours: CC 20% vs. PP 8%, P = 0.038. Clonidine resulted in a number of significant (P < 0.05) haemodynamic changes, particularly pre-CPB: less tachycardia and hypertension, more bradycardia and hypotension. Clonidine was associated with a significant (P < 0.05) reduction in anaesthetic drug usage, higher creatinine clearance, lower cortisol excretion and improvement in some aspects of quality of life. This study lends support to consideration of clonidine therapy in patients undergoing CABG surgery.

UNLABELLED:A variety of methods have been used to quantify aspects of recovery after anesthesia. Most are narrowly focused, are not patient-rated, and have not been validated. We therefore set out to develop a patient-rated quality of recovery score. We constructed a 61-item questionnaire that asked individuals (patients and relatives, medical and nursing staff; total n = 136) to rate various postoperative items describing features a patient may experience postoperatively. The most highly ranked items were included in a final nine-point index score, which we called the "QoR Score." We then studied two cohorts of surgical patients (n = 449). There was good convergent validity between the QoR Score and the visual analog scale score (rho = 0.55, P < 0.0001). Discriminant construct validity was supported by comparing resultant QoR Scores in patients undergoing day-stay, minor, and major surgery (P = 0.008), as well as a negative correlation with duration of hospital stay (rho = -0.20, P < 0.0001), and, using multivariate regression, demonstrating a significant negative relationship between QoR Score and female gender (P = 0.048) and older age (P = 0.041). There was also good interrater agreement (rho = 0.55, P < 0.0001), test-retest reliability (median rho = 0.61, P < 0.0001), and internal consistency (alpha = 0.57 and 0.90, P < 0.0001). There was a significant difference between the groups of patients recovering from major and minor surgery (P < 0.001). This study demonstrates that the QoR Score has good validity, reliability, and clinical acceptability in patients undergoing many types of surgery. IMPLICATIONS:We set out to develop a patient-rated quality of recovery score (QoR) that could be used both as a measure of outcome in perioperative trials and for clinical audit. We first surveyed patients and staff to identify important aspects of recovery, then developed a nine-point QoR Score. This was then compared with other measures of postoperative outcome. We found that the QoR Score is a useful measure of recovery after anesthesia and surgery.

BACKGROUND:The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns.METHODS:After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified.RESULTS:The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57).CONCLUSIONS:No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.

Recent interest in earlier tracheal extubation after coronary artery bypass graft (CABG) surgery has focused attention on the potential benefits of a propofol-based technique. We randomized 124 patients (34 with poor ventricular function) undergoing CABG surgery to receive either a propofol-based (5 mg [center dot] kg-1 [centered dot] h-1 prior to sternotomy, 3 mg [center dot] kg-1 [center dot] h (-1) thereafter; n = 58) or enflurane-based (0.2%-1.0%, n = 66) anesthetic. Induction of anesthesia consisted of fentanyl 15 micro g/kg and midazolam 0.05 mg/kg intravenously in both groups. The enflurane group received an additional bolus of fentanyl 5 micro g/kg prior to sternotomy and fentanyl 10 micro g/kg with midazolam 0.1 mg/kg at commencement of cardiopulmonary bypass (CPB). Patients receiving propofol were extubated earlier (median 9.1 h versus 12.3 h, P = 0.006), although there was no difference in time to intensive care unit (ICU) discharge (both 22 h, P = 0.54). Both groups had similar hemodynamic changes throughout (all P > 0.10), as well as metaraminol (P = 0.49) and inotrope requirements (P > 0.10), intraoperative myocardial ischemia (P = 0.12) and perioperative myocardial infarction (P = 0.50). The results of this trial suggest that a propofol-based anesthetic, when compared to an enflurane-based anesthetic requiring additional dosing of fentanyl and midazolam for CPB, can lead to a significant reduction in time to extubation after CABG surgery, without adverse hemodynamic effects, increased risk of myocardial ischemia or infarction. (Anesth Analg 1997;84:12-9)

We compared the incidence of postoperative complications in women (vs. men) in 4173 patients. Overall, women were almost twice as likely to report any postoperative complication (RR = 1.92, p < 0.0005). Specifically, they were 2.6 times more likely to report nausea and vomiting (p < 0.0005), 1.5 times more likely to report sore throat (p = 0.0001), 2.3 times more likely to report headache (p < 0.0005) and 2.4 times more likely to report backache (p = 0.0036). Whether these gender differences are due to a reporting bias, or whether in fact women are at greater risk of such complications, remains to be determined.

We compared the incidence of postoperative complications in women (vs. men) in 4173 patients. Overall, women were almost twice as likely to report any postoperative complication (RR = 1.92, p < 0.0005). Specifically, they were 2.6 times more likely to report nausea and vomiting (p < 0.0005), 1.5 times more likely to report sore throat (p = 0.0001), 2.3 times more likely to report headache (p < 0.0005) and 2.4 times more likely to report backache (p = 0.0036). Whether these gender differences are due to a reporting bias, or whether in fact women are at greater risk of such complications, remains to be determined.

We studied the relationship between oxygen delivery (DO2) and consumption (VO2) in twenty patients undergoing cardiac surgery, in order to determine if VO2 was dependent on DO2 (pathological oxygen supply dependence). We measured VO2 from expired gas analysis (VO2G) and compared this to that calculated using the reverse Fick method (VO2F). Both VO2G and VO2F increased after cardiopulmonary bypass (P<0.001), without change in DO2 (i.e. oxygen extraction ratio increased). There was a significant relationship between changes in DO2 and VO2F, both before bypass (r=0.74, P<0.001) and after bypass (r=0.69, P<0.001), while changes in DO2 and VO2G had no such relationship (pre-bypass: r=0.38, P=0.094; post-bypass: r=0.10, P=0.68). There was poor agreement between VO2F and VO2G perioperatively. We could not demonstrate supply dependence in elective cardiac surgical patients.

Fifty registered nurses were interviewed to determine how nurses view routine post anaesthetic observations (RPAOs). A structured interview established whether nurses routinely carry out post anaesthetic observations and if they believe that routine observations are part of ward procedure or hospital policy. Nurses' beliefs about the necessity for performing these observations and the rationales they use to justify them were also explored. The results show that all the nurses sampled interpreted RPAOs to mean half hourly vital sign measurements for four hours, and believed that the regimen was prescribed by ward or hospital policy. Many believed that this frequency was necessary to detect complications of surgery or anaesthesia. A small number of nurses felt obliged to comply with perceived hospital policy despite an assessment that it was unnecessary. Procedure-driven assessment and tradition rather than individualized patient assessment appear to be directing post operative nursing actions.