Autonomy and consent assessment for electroconvulsive therapy (ECT). A retrospective study of medical records.

The Norwegian Mental Health Act allows involuntary treatment for patients who lack consent capacity, however it allows only administration of pharmaceutical treatment and nutrition and not ECT. In lack of specific regulations, the legal access to ECT without valid consent has been grounded on the general rule of necessity in the Norwegian Penal code. This restriction and lack of legal regulation has implications for patients' rights and legal security. The study's aim was to assess the documented consent provided by patients for electroconvulsive therapy (ECT), whether ECT was administered without valid consent or under coercion, and the documented reasons, and ultimately compare practice with the legal requirements. We analysed systematically all the relevant medical records for hospitalised patients and outpatients receiving ECT during 2011-2016. We categorized data from these two groups into seven defined categories describing the attitude and quality of the consents to the ECT (or lack thereof). 378 patients received 498 ECT series´. The noted consents varied from treatment based on request (54 treatments), consent upon recommendation (209 treatments), consent after hesitation (88 treatments), consent presumed or noted without specification (114 treatments), to no consent (21 treatments) whereof the majority with documented coercion applied (19 treatments). All cases of ECT without consent referred to a "plea of necessity". The remaining treatments (12) lacked notifications specifying the consent (or attitude) expressed. Specific notes on the patient's capacity to consent for the respective ECT were generally lacking. This study indicates a large spread in patients´ acceptance and valid consent to ECT. The main reason for administering ECT without consent and/or against patients' will was for life-saving reasons. Such treatments were justified legal under a plea of necessity in the Penal Code or lacked noted legal justification. The legal vacuum for ECT without a valid consent needs to be addressed as this kind of disputed treatment is used in some cases.

Maternal haemodynamics during labour epidural analgesia with and without adrenaline.

OBJECTIVES: Labour is one of the most painful experiences in a woman's life. Epidural analgesia using low-concentration local anaesthetics and lipophilic opioids is the gold standard for pain relief during labour. Pregnancy in general, particularly labour, is associated with changes in maternal haemodynamic variables, such as cardiac output and heart rate, which increase and peak during uterine contractions. Adrenaline is added to labour epidural solutions to enhance efficacy by stimulating the α2-adrenoreceptor. The minimal effective concentration of adrenaline was found to be 2 µg mL-1 for postoperative analgesia. The addition of adrenaline may also produce vasoconstriction, limiting the absorption of fentanyl into the systemic circulation, thereby reducing foetal exposure. However, adrenaline may influence the haemodynamic fluctuations, possibly adding to the strain on the circulatory system. The aim of this study was to compare the haemodynamic changes after application of labour epidural analgesia with or without adrenaline 2 µg mL-1. METHODS: This was a secondary analysis of a single-centre, randomised double-blind trial. Forty-one nulliparous women in labour requesting epidural analgesia were randomised to receive epidural solution of bupivacaine 1 mg mL-1, fentanyl 2 µg mL-1 with or without adrenaline 2 µg mL-1. The participants were monitored using a Nexfin CC continuous non-invasive blood pressure and cardiac output monitor. The primary outcomes were changes in peak systolic blood pressure and cardiac output during uterine contraction within 30 min after epidural activation. The effect of adrenaline was tested statistically using a linear mixed-effects model of the outcome variables' dependency on time, adrenaline, and their interaction. RESULTS: After excluding three patients due to poor data quality and two due to a malfunctioning epidural catheter, 36 patients (18 in each group) were analysed. The addition of adrenaline to the solution had no significant effect on the temporal changes in peak systolic blood pressure (p=0.26), peak cardiac output (0.84), or heart rate (p=0.91). Furthermore, no significant temporal changes in maternal haemodynamics (peak systolic blood pressure, p=0.54, peak cardiac output, p=0.59, or heart rate p=0.55) were associated with epidural analgesia during 30 min after epidural activation in both groups despite good analgesia. CONCLUSIONS: The addition of 2 µg mL-1 adrenaline to the epidural solution is not likely to change maternal haemodynamics during labour.

Programmed intermittent boluses vs continuous epidural infusion in labor using an adrenaline containing solution: A randomized trial.

BACKGROUND: Traditionally, epidural analgesia has been maintained using a continuous infusion (CEI) with the addition of patient-controlled boluses (PCEA). In recent years, programmed intermittent boluses (PIEB) has emerged as an alternative showing better efficacy in randomized studies. In this study, the aim was to test PIEB + PCEA vs CEI + PCEA using an epidural solution containing adrenaline. METHODS: In total, 150 nulliparous and multiparous laboring women were randomized to maintain epidural analgesia with either PIEB + PCEA (5 ml bolus every hour, 5 ml PCEA bolus lockout 20 minutes) or CEI + PCEA (5 ml/h, 5 ml PCEA bolus, lockout 20 minutes) using a solution of bupivacaine 1mg/ml, fentanyl 2 mcg/ml and adrenaline 2 mcg/ml. The primary outcome was total hourly consumption of the epidural solution. Secondary outcomes included hourly pain scores, motor block at 60 minutes and 10 cm cervical dilation, maternal satisfaction, and the need for anesthetist intervention and time to this intervention. RESULTS: We found no differences in hourly drug consumption between the groups (mean 9.0 ml/h (SD 3.7) (CEI group) vs. 8.1 ml/h (SD 2.0) (PIEB group), P = .08). We found a significant difference in number of successfully administered PCEA boluses (mean no. 3.9 (SD 4.1) (CEI group) vs. 1.9 (SD 2.0) (PIEB group), P < .001). We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention. CONCLUSION: In this study, we found no clinically relevant differences using PIEB + PCEA compared to CEI + PCEA when using an epidural solution containing adrenaline. EDITORIAL COMMENT: For labor epidural analgesia infusions, to optimize the analgesic effect, additional programmed intermittent boluses can be used as an alternative to patient-controlled boluses only. In this clinical trial, no differences in drug consumption or analgesic effect was observed when comparing these two different epidural bolus controls programs.

The influences of morphine or ketamine pre-treatment on hemodynamic, acid-base status, biochemical markers of brain damage and early survival in rats after asphyxial cardiac arrest.

BACKGROUND: In different models of hypoxia, blockade of opioid or N-methyl-D-aspartate (NMDA) receptors shows cardio- and neuroprotective effects with a consequent increase in animal survival. The aim of the study was to investigate effects of pre-treatment with Morphine or Ketamine on hemodynamic, acid-base status, early survival, and biochemical markers of brain damage in a rat model of asphyxial cardiac arrest (ACA). METHODS: Under anaesthesia with Thiopental Sodium 60 mg/kg, i.p., Wistar rats (n = 42) were tracheostomized and catheters were inserted in a femoral vein and artery. After randomization, the rats were pre-treated with: Morphine 5 mg/kg i.v. (n = 14); Ketamine 40 mg/kg i.v. (n = 14); or equal volume of i.v. NaCl 0.9% as a Control (n = 14). ACA was induced by corking of the tracheal tube for 8 min, and defined as a mean arterial pressure (MAP) < 20 mmHg. Resuscitation was started at 5 min after cardiac arrest (CA). Invasive MAP was recorded during experiments. Arterial pH and blood gases were sampled at baseline (BL) and 10 min after CA. At the end of experiments, all surviving rats were euthanised, brain and blood samples for measurement of Neuron Specific Enolase (NSE), s100 calcium binding protein B (s100B) and Caspase-3 (CS-3) were retrieved. RESULTS: At BL no differences between groups were found in hemodynamic or acid-base status. After 3 min of asphyxia, all animals had cardiac arrest (CA). Return of spontaneous circulation (MAP > 60 mmHg) was achieved in all animals within 3 min after CA. At the end of the experiment, the Ketamine pre-treated group had increased survival (13 of 14; 93%) compared to the Control (7 of 14; 50%) and Morphine (10 of 14; 72%) groups (p = 0.035). Biochemical analysis of plasma concentration of NSE and s100B as well as an analysis of CS-3 levels in the brain tissue did not reveal any differences between the study groups. CONCLUSION: In rats after ACA, pre-treatment with Morphine or Ketamine did not have any significant influence on hemodynamic and biochemical markers of brain damage. However, significantly better pH level and increased early survival were found in the Ketamine pre-treated group.

Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway.

BACKGROUND: Respect for patient autonomy and the requirement of informed consent is an essential basic patient right. It is constituted through international conventions and implemented in health law in Norway and most other countries. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. In this study, we investigated how surgeons recorded decisions in situations where the elderly patient's ability to provide a valid informed consent was questionable or clearly missing. METHOD: We investigated all medical records of patients admitted to surgical departments in a Norwegian large academic emergency hospital over a period of 38 days (approximately 5000 patients). We selected records of patients above the age of 70 (570 patients) and searched through these 570 medical records for any noted clear indications of inability to consent such as "do not understand", "confused" etc. (102 patients). We read through all the medical records on these 102 patients noting any recordings on lack of informed consent, any recordings on reasoning and process hereto. We also took note whether there were clear indications on the use of coercion. RESULTS: None of the 102 included patients´ charts contained legally valid recorded assessments (for example related to the patients´ competence to consent) when patients without the ability to consent were admitted and provided healthcare.Some charts contained records that the patient resisted treatment, thus indicating treatment with coercion. In these situations, we did not find any documentation related to legal requirements that regulate the use of coercion. DISCUSSION AND CONCLUSION: We found a substantial lack of compliance with the legal requirements that apply when obtaining valid informed consent. There are many possible reasons for this: Lack of knowledge of the legal requirements, disagreement about the rules, or that it is simply not possible to comply with the extensive formal and material legal requirements in clinical practice. The results do not point out whether the appropriate measures are amending the law, educating and requiring more compliance from surgeons, or both.

Guidelines for treatment of sepsis. / Retningslinjer for behandling av sepsis.

BAKGRUNN: Det finnes internasjonale og nasjonale retningslinjer for behandling av sepsis. I tillegg har nesten alle norske sykehus utarbeidet egne retningslinjer for behandling av tilstanden. Formålet med denne studien var å vurdere i hvilken grad de lokale retningslinjene stemmer overens med de nasjonale. MATERIALE OG METODE: Alle offentlige norske sykehus med indremedisinsk akuttfunksjon ble kontaktet og forespurt om lokale retningslinjer for behandling av sepsis. De lokale retningslinjene ble sammenlignet med nasjonale retningslinjer. RESULTATER: 43 av 48 sykehus besvarte henvendelsen. 36 sykehus hadde lokale retningslinjer, ti av disse hadde retningslinjer utarbeidet ved et større sykehus. Syv sykehus oppga at de brukte nasjonale eller internasjonale retningslinjer direkte, fire av disse oppga at deres egne lokale retningslinjer var utdatert eller under revisjon. De lokale retningslinjene var i grove trekk samsvarende med de nasjonale, selv om flere hadde mindre ulikheter hva gjaldt antibiotikabehandling, væskebehandling, vasoaktive medikamenter og inotrope medikamenter. FORTOLKNING: Majoriteten av norske sykehus hadde lokale retningslinjer for behandling av sepsis. De lokale retningslinjene samsvarte godt med de nasjonale, selv om det var forskjeller og uenigheter knyttet til enkelte aspekter ved behandlingen.

Older patients with late-stage COPD: Their illness experiences and involvement in decision-making regarding mechanical ventilation and noninvasive ventilation.

AIMS AND OBJECTIVES: To explore the illness experiences of older patients with late-stage chronic obstructive pulmonary disease and to develop knowledge about how patients perceive their preferences to be taken into account in decision-making processes concerning mechanical ventilation and/or noninvasive ventilation. BACKGROUND: Decisions about whether older patients with late-stage chronic obstructive pulmonary disease will benefit from noninvasive ventilation treatment or whether the time has come for palliative treatment are complicated, both medically and ethically. Knowledge regarding patients' values and preferences concerning ventilation support is crucial yet often lacking. DESIGN: Qualitative design with a hermeneutic-phenomenological approach. METHODS: The data consist of qualitative in-depth interviews with 12 patients from Norway diagnosed with late-stage chronic obstructive pulmonary disease. The data were analysed within the three interpretative contexts described by Kvale and Brinkmann. RESULTS: The participants described their lives as fragile and burdensome, frequently interrupted by unpredictable and frightening exacerbations. They lacked information about their diagnosis and prognosis and were often not included in decisions about noninvasive ventilation or mechanical ventilation. CONCLUSION: Findings indicate that these patients are highly vulnerable and have complex needs in terms of nursing care and medical treatment. Moreover, they need access to proactive advanced care planning and an opportunity to discuss their wishes for treatment and care. RELEVANCE TO CLINICAL PRACTICE: To provide competent care for these patients, healthcare personnel must be aware of how patients experience being seriously ill. Advanced care planning and shared decision-making should be initiated alongside the curative treatment.

Effects on nutritional care practice after implementation of a flow chart-based nutrition support protocol in an intensive care unit.

BACKGROUND: Enteral nutrition (EN) is associated with improved outcome in critically ill patients and is more affordable. We compared nutritional care practice in our ICU before and after modification of our nutrition support protocol: Several comprehensive documents were substituted with one flow chart and early EN was encouraged. DESIGN: Retrospective observational study. METHODS: Nutritional data were collected from admission up to 7 days in 25 patients before and 25 patients after protocol modification. RESULTS: The percentage of patients receiving EN within 72 hr of admission increased from 64% before to 88% after protocol modification. Cumulative percentage energy from EN during ICU days 1-4 increased from 26-89% of total kcal. Overall amount of nutrition administered enterally increased, with a corresponding marked decline in use of parenteral nutrition. Pre-modification, >80% of patients received >65% of their calculated nutrition requirements by ICU Day 4; post-modification this goal was achieved by Day 7.

Influence of a New "Call-Out Algorithm" for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial.

BACKGROUND: We recently introduced the efficacy safety score (ESS) as a new "call-out algorithm" for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS). METHODS: We randomized 1152 surgical patients into three groups for postoperative observation: (1) ESS group (n = 409), (2) Verbal Numeric Rate Scale (VNRS) for pain group (n = 417), and (3) an ordinary qualitative observation (Control) group (n = 326). An ESS > 10 or VNRS > 4 at rest or a nurse's observation of pain or adverse reaction to analgesic treatment in the Control group served as a "call-out alarm" for an anaesthesiologist. RESULTS: We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7 ± 6.3 days (mean ± SD) in the ESS group versus 14.2 ± 6.2 days in the Control group (P < 0.001). CONCLUSION: Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128.

Factors associated with life-sustaining treatment restriction in a general intensive care unit.

PURPOSE: Few previous studies have investigated associations between clinical variables available after 24 hours in the intensive care unit (ICU), including the Charlson Comorbidity Index (CCI), and decisions to restrict life-sustaining treatment. The aim of this study was to identify factors associated with the life-sustaining treatment restriction and to explore if CCI contributes to explaining decisions to restrict life-sustaining treatment in the ICU at a university hospital in Norway from 2007 to 2009. METHODS: Patients' Simplified Acute Physiology Score II (SAPS II), age, sex, type of admission, and length of hospital stay prior to being admitted to the unit were recorded. We retrospectively registered the CCI for all patients based on the medical records prior to the index stay. A multivariable logistic regression analysis was used to assess factors associated with treatment restriction during the ICU stay. RESULTS: We included 936 patients, comprising 685 (73%) medical, 204 (22%) unscheduled and 47 (5%) scheduled surgical patients. Treatment restriction was experienced by 241 (26%) patients during their ICU stay. The variables that were significantly associated with treatment restriction in multivariable analysis were older age (odds ratio [OR] = 1.48 per 10 years, 95% confidence interval [CI] = 1.28-1.72 per 10 years), higher SAPS II (OR = 1.05, 95% CI = 1.04-1.07) and CCI values relative to the reference of CCI = 0: CCI = 2 (OR = 2.08, 95% CI = 1.20-3.61) and CCI≥3 (OR = 2.72, 95% CI = 1.65-4.47). CONCLUSIONS: In multivariable analysis, older age, greater illness severity after 24 h in the ICU and greater comorbidity at hospital admission were independently associated with subsequent life-sustaining treatment restriction. The CCI score contributed additional information independent of the SAPS II illness severity rating.

Development and validation of the Efficacy Safety Score (ESS), a novel tool for postoperative patient management.

BACKGROUND: Several reports have shown that postoperative monitoring of general safety and quality issues, including pain treatment, after discharge from recovery is often non-systematic and inadequate. We suggest a new score with assessment of key recovery parameters, as a supportive tool for postoperative care and a call-out algorithm for need of extra help. The aim of this investigation was to validate the score. METHODS: After suggesting a prototype score from a pilot study in 182 postoperative patients, we performed a Delphi process by using international experts to create consensus on the final score contents and called the revised tool the Efficacy Safety Score (ESS). Then, we performed a prospective observational study with the ESS throughout the first 24 h postoperatively in 207 surgical in-patients. We compared ESS with Modified Early Warning Systems (MEWS), and postoperative journal information. We subsequently validated ESS by addressing recognized quality criteria for measurement of health status questionnaires. RESULTS: A call-out value of ESS ≥10 correlated with MEWS > 0 values and journal information about postoperative concerns with a sensitivity of 94% and 92%, respectively. All serious safety issues were identified with the ESS ≥ 10, and a higher number of quality issues were identified than with routine care or MEWS. We obtained positive ratings for six out of seven tested criteria of questionnaire quality; one criterion had an indeterminate rating. CONCLUSION: ESS fulfils suggested criteria for score quality validation and reflects the patient's postoperative status adequately and with high sensitivity. Further clinical trials are warranted to evaluate the usefulness of ESS as a simple tool for assessment of the postoperative safety and quality of patients.

Nurses' role and care practices in decision-making regarding artificial ventilation in late stage pulmonary disease.

BACKGROUND: Decisions regarding whether or not to institute mechanical ventilation during the later stages of chronic obstructive pulmonary disease is challenging both ethically, emotionally and medically. Caring for these patients is a multifaceted process where nurses play a crucial role. Research question and design: We have investigated how nurses experienced their own role in decision-making processes regarding mechanical ventilation in later stages of chronic obstructive pulmonary disease and how they consider the patients' role in these processes. We applied a qualitative approach, with six focus-group interviews of nurses (n = 26). Ethical considerations: The Regional Committees for Medical and Health Research Ethics approved the study. Voluntary informed consent was obtained. FINDINGS: The nurses found themselves operating within a cure-directed treatment culture wherein they were unable to stand up for the caring values. They perceived their roles and responsibilities in decision-making processes regarding mechanical ventilation to patients as unclear and unsatisfactory. They also experienced inadequate interdisciplinary cooperation. DISCUSSION: Lack of communication skills, the traditional hierarchical hospital culture together with operating in a medical-orientated treatment culture where caring values is rated as less important might explain the nurses' absence in participation in the decision about mechanical ventilation. CONCLUSION: To be able to advocate for the patients' and their own right to be included in decision-making processes, nurses need an awareness of their own responsibilities. This requires personal courage, leadership who are capable of organising common interpersonal meetings and willingness on the part of the physicians to include and value the nurses' participation in decision-making processes.

Hemodynamics of Phenylephrine Infusion Versus Lower Extremity Compression During Spinal Anesthesia for Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND: Phenylephrine infusion is the current first-line choice for prevention of spinal hypotension during cesarean delivery. The optimal dosage regimen is still undetermined. A mechanical alternative, lower limb wrapping, has been examined in a few small studies showing moderate success. In this trial, we compared the effect of leg wrapping with low-dose phenylephrine infusion and with placebo treatment on systolic arterial blood pressure during spinal anesthesia for cesarean delivery. METHODS: In this randomized, double-blinded, placebo-controlled study, healthy women received either phenylephrine (n = 38; initial bolus of 0.25 µg kg and infusion of 0.25 µg kg min), leg wrapping (n = 38), or no treatment (control; n = 36) during spinal anesthesia for elective cesarean delivery. LiDCOplus was used for continuous minimally invasive hemodynamic monitoring. The extent of decrease in systolic arterial blood pressure (for 13 minutes after spinal induction) was the primary outcome. Cardiac output, systemic vascular resistance, stroke volume, heart rate, neonatal acid-base status, and Apgar score were secondary outcome variables. Mixed model analysis of continuous hemodynamic trends during the first 13 minutes after induction of spinal anesthesia was performed. RESULTS: In the phenylephrine group, the decrease in systolic arterial blood pressure was significantly less (difference in rate of change, 0.09 mm Hg 5 s; 95% confidence interval, 0.02-0.16; P = 0.013); systemic vascular resistance (P < 0.001) was significantly higher; stroke volume (P = 0.41) was similar; and heart rate (P = 0.002) and cardiac output (P < 0.001) were significantly lower compared with the leg wrapping group. Compared with control, the leg wrapping group had a significantly smaller decrease in systolic arterial blood pressure (0.39 mm Hg 5 s; 95% confidence interval, 0.32-0.46; P < 0.001), higher stroke volume (P < 0.001), and higher cardiac output (P = 0.001). CONCLUSIONS: An initial bolus of phenylephrine followed by a low-dose phenylephrine infusion was superior to leg wrapping and no intervention for the prevention of hypotension during spinal anesthesia for cesarean delivery. Phenylephrine prevented hypotension primarily by restoring systemic vascular resistance and did not cause hypertension or a clinically relevant reduction in cardiac output. Leg wrapping prevented hypotension compared with no intervention by limiting modest early spinal anesthesia-mediated venodilation.

Prolonging the duration of single-shot intrathecal labour analgesia with morphine: A systematic review.

BACKGROUND AND AIMS: Single-shot spinal with bupivacaine plus fentanyl or sufentanil is commonly used as analgesia during labour, but the short duration limits the clinical feasibility. Different drugs have been added to prolong the analgesic duration. The additional effect of intra-thecal morphine has been studied during labour pain as well as after surgery. We assessed whether adding morphine to intra-thecal bupivacaine+fentanyl or sufentanil prolongs pain relief during labour. METHODS: Meta-analysis of placebo-controlled randomized clinical trials of analgesia prolongation after single-shot intrathecal morphine ≤250µg during labour when given in combination with bupivacaine+fentanyl or sufentanil. After identifying 461 references, 24 eligible studies were evaluated after excluding duplicate publications, case reports, studies of analgesia after caesarean delivery, and epidural labour analgesia. Mean duration in minutes was the primary outcome measure and was included in the calculation of the standardized mean difference. Duration was defined as the time between a single shot spinal until patient request of rescue analgesia. All reported side effects were registered. Results of individual trials were combined using a random effect model. Cochrane tool was used to assess risk of bias. RESULTS: Five randomized placebo-controlled clinical trials (286 patients) were included in the meta-analysis. A dose of 50-250µg intrathecal morphine prolonged labour analgesia by a mean of 60.6min (range 3-155min). Adding morphine demonstrated a medium beneficial effect as we found a pooled effect of standardized mean difference=0.57 (95% CI: -0.10 to 1.24) with high heterogeneity (I2=88.1%). However, the beneficial effect was statistically non-significant (z=1.66, p=0.096). The lower-bias trials showed a small statistically non-significant beneficial effect with lower heterogeneity. In influential analysis, that excluded one study at a time from the meta-analysis, the effect size appears unstable and the results indicate no robustness of effect. Omitting the study with highest effects size reduces the pooled effect markedly and that study suffers from inadequate concealment of treatment allocation and blinding. Trial quality was generally low, and there were too few trials to explore sources of heterogeneity in meta-regression and stratified analyses. In general, performing meta-analyses on a small number of trials are possible and may be helpful if one is aware of the limitations. As few as one more placebo-controlled trial would increase the reliability greatly. CONCLUSIONS: Evidence from this systematic review suggests a possible beneficial prolonging effect of adding morphine to spinal analgesia with bupivacaine+fentanyl or +sufentanil during labour. The study quality was low and heterogeneity high. No severe side effects were reported. More adequately-powered randomized trials with low bias are needed to determine the benefits and harms of adding morphine to spinal local anaesthetic analgesia during labour. IMPLICATIONS: Epidural analgesia is documented as the most effective method for providing pain relief during labour, but from a global perspective most women in labour have no access to epidural analgesia. Adding morphine to single shot spinal injection of low dose bupivacaine, fentanyl or sufentanil may be efficacious but needs to be investigated.

Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects.

BACKGROUND: This study compared efficacy and safety of the selective relaxant binding agent sugammadex (2 mg/kg) with neostigmine (50 µg/kg) for neuromuscular blockade (NMB) reversal in Chinese and Caucasian subjects. METHODS: This was a randomized, active-controlled, multicenter, safety-assessor-blinded study (NCT00825812) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia. Rocuronium 0.6 mg/kg was administered for endotracheal intubation, with 0.1-0.2 mg/kg maintenance doses given as required. NMB was monitored using TOF-Watch(®) SX. At second twitch reappearance, after last rocuronium dose, subjects received sugammadex 2 mg/kg or neostigmine 50 µg/kg plus atropine 10-20 µg/kg, according to randomization. Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four (TOF) ratio to 0.9. RESULTS: Overall, 230 Chinese subjects (sugammadex, n = 119, neostigmine, n = 111); and 59 Caucasian subjects (sugammadex, n = 29, neostigmine, n = 30) had evaluable data. Geometric mean (95% CI) time to recovery to TOF ratio 0.9 was 1.6 (1.5-1.7) min with sugammadex vs 9.1 (8.0-10.3) min with neostigmine in Chinese subjects. Corresponding times for Caucasian subjects were 1.4 (1.3-1.5) min and 6.7 (5.5-8.0) min, respectively. Sugammadex 2 mg/kg was generally well tolerated, with no serious adverse events reported. There was no residual NMB or recurrence of NMB. CONCLUSION: Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2 mg/kg vs neostigmine 50 µg/kg, with a ~5.7 times (p < 0.0001) faster recovery with sugammadex vs neostigmine in Chinese subjects. Sugammadex was generally well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00825812.