ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31356 results sorted by trial registration date.
  • A randomized trial of sevoflurane versus desflurane on the quality of recovery following knee arthroscopy

    Aims: To identify whether the quality of recovery over time is affected by sevoflurane versus desflurane when used as the primary anaesthetic for knee arthroscopy surgery. Significance: Quality of recovery is an emerging field within anaesthesia of great importance. Although large outcome studies are very important in anaesthesia, there is a changing focus from “mortality and morbidity studies”, to quality of recovery. The reason is that the frequency of mortality is now very low with the result that few interventions will further reduce mortality. Very large numbers are required to demonstrate any improvements in surgery and anaesthesia when mortality is used as an outcome. However early data on the PQRS as well as clinical reports indicate that the quality of recovery is often poor in many patients, and yet these are not identified by the treating anaesthetist. There are implications for the individual patient, for the practice of anaesthesia, and for the community (such as safe return to work or to driving). Knee arthroscopy is often performed as an outpatient (day) procedure, and therefore may be perceived as “minor surgery”. However, for some patients the quality of recovery including cognitive decline may be more profound than would be expected from brief peripheral surgery. The role of the anaesthetic agent may have an important influence on this recovery. It is frequently assumed by anaesthetists that anaesthetics from the same class should produce similar effects when administered for a brief anaesthetic, but there are insufficient data to validate that assumption. This study will help anaesthetists to choose the anaesthetic that is best for their patients undergoing brief surgery. Hypothesis: The null hypothesis is that there is no difference in recovery in all domains measured using the PQRS, in patients undergoing knee arthroscopy under general anaesthesia with either sevoflurane or desflurane as the primary anaesthetic Methods: A parallel group, randomised trial with 1:1 allocation ratio will be conducted in adult patients undergoing arthroscopy, where the intervention is to receive sevoflurane or desflurane as the primary anaesthetic agent. Quality of recovery will be measured using the Post-operative Quality of Recovery Scale (PQRS), at baseline (preoperative), 15 and 40 minutes, one and three days, and three months following surgery. Patients who are unable to complete the PQRS due to language limitations, or who will receive regional anaesthesia will be excluded. Recovery is defined as “return to baseline values or better” for each of the survey questions and is dichotomised to recovered or not recovered. Recovery is grouped within domains (physiological, emotive, nociceptive, cognitive, and activities of daily living, with a sixth domain of self-assessment). The primary endpoint will be the incidence of recovery for all domains (not including self-assessment) on the third day after surgery. Based on a pilot study performed at the Epworth Hospital, we estimate the ability to detect a clinically important difference with 150 patients in each group. Guidelines for other aspects of patient care including co-induction agents, antiemetics, and post-operative analgesics will be issued to reduce variability between patients. Likely benefits: There are pharmacological differences between sevoflurane and desflurane that make them more or less attractive to the anesthetist. Desflurane, should provide for earlier and more complete recovery then sevoflurane, but sevoflurane is an easier drug to administer due to a lower incidence of airway irritability. There are very few data investigating quality of recovery with these two drugs beyond emergence and PACU care. This study will provide data into whether there are longer-term differences in the quality of recovery between these two drugs.

  • A randomised trial of propofol sedation versus desflurane anaesthesia, used to supplement spinal anaesthesia, on the quality of recovery following hip replacement surgery in adult patients

    The study aims to assess whether two different anaesthetic techniques can affect the postoperative quality of recovery in patients undergoing total hip replacement surgery. The two techniques are considered as sedation or light general anaesthesia as they supplement a spinal anaesthetic - which is the primary anaesthetic technique for these patients. The quality of recovery is measured using a scale called the PQRS, which measures recovery in a number of different domains and compares recovery to the patients pre-surgery values.

  • Effect of non-invasive ventilation during exercise on dynamic hyperinflation in chronic obstructive pulmonary disease

    AIM: The aim of this study is to determine the effect of NIV during exercise on DHI (Dynamic HyperInflation) in people with COPD (Chronic Obstructive Pulmonary Disease) compared to exercise without NIV (Noninvasive Ventilation). NIV with two different settings, standard and individualised, will be compared with no NIV. HYPOTHESIS: Non-invasive ventilation during exercise will reduce dynamic hyperinflation and increase exercise endurance time in people with COPD who dynamically hyperinflate during exercise compared to exercise without NIV. Individualised NIV will be more effective than standard NIV and no NIV in reducing DHI during exercise. POTENTIAL SIGNIFICANCE: Breathlessness is a major symptom for patients with severe COPD impacting adversely on physical performance and quality of life. The immediate effects of NIV during exercise include significant improvements in breathlessness and exercise endurance beyond those achieved with unassisted breathing in selected patients with severe COPD. These acute effects could significantly improve the efficacy of a pulmonary rehabilitation program by enabling people with COPD to exercise for longer or at a higher intensity.

  • Stepping Stones Triple P Project: A population trial of a parenting program for parents with children with disabilities

    The Stepping Stones Project aims to address the significant, unmet mental health needs of young people with disabilities and their families. This project will raise awareness of the importance of early intervention for emotional and behavioural problems in young people with disabilities and improve access to the evidence-based positive parenting intervention, Stepping Stones Triple P. As part of the study, parents and caregivers of children with a disability aged 2-12 will be able to access free Stepping Stones Triple P parenting programs. Professionals will be able to access free training in Stepping Stones Triple P. Stepping Stones Triple P programs will gradually become available across Queensland, Victoria and New South Wales. It is expected that participating in Stepping Stones Triple P parenting programs will lead to individual and population-wide reductions in child behavioural and emotional difficulties and parent stress, and improve access to evidence-based parenting programs in the community.

  • Bleeding and clotting complications in patients having liver surgery

    This is an observational study evaluating bleeding and clotting complications in patients undergoing liver surgery for cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are undergoing hepatic resection (i.e. surgical removal of all or a portion of the liver) for malignancy at Peter MacCallum Cancer Centre. Study details Changes to the blood clotting system following liver surgery have not been well characterised and information is conflicting. The traditional view is that as the liver makes important clotting factors surgery would reduce this production and make patients more likely to bleed. However, some recent work has suggested that actually liver resection patients are prone to blood clotting and the bigger the surgery the higher the risk. This study aims to use laboratory tests of coagulation to determine what actually occurs. Patients will be observed from the day of surgery until 1 year post surgery with review points at: Day 1, Day 3, Day 5 (if certain conditions met), week 2-3 (clinic review time), week 4-6 (clinic review time) and 1 year (clinic review time). Data collected from this study will help us to develop guidelines for management of blood clotting around the time of liver surgery. Additionally, the rate of bleeding and clotting complications will also be recorded.

  • Correlation between alcohol concentration and an electroencephalogram (EEG) measure of anaesthetic depth

    Bispectral Index monitoring is commonly used intraoperatively to decrease the risk of awareness. Multiple drugs are known to affect the bispectral index and many have been studied in detail. Our aim is to determine the relationship between alcohol concentration and BIS. Awareness is an uncommon but potentially stressful complication of anaesthesia occurring in 0.1-0.2% of surgical patients.[1] The BIS monitor processes EEG activity with time-domain, frequency domain, and bispectral analysis producing a dimensionless number between 0 and 100 with 40-60 being appropriate for surgery.[2] Large trials have shown a decrease in the occurrence of awareness when using BIS in high-risk patients.[1, 3] Studies have demonstrated that BIS decreases in patients with head injuries [4, 5], those with cognitive impairment such as dementia [6] and with sedation [7]. There has been a single case report detailing a case of intracranial arterial alcohol embolization in which the BIS decreased to zero[8]. We hypothesise that BIS will decrease with alcohol consumption. The effect of multiple drugs such as nitrous oxide, ketamine and opioid on bispectral index has been studied in detail.[2] Alcohol, a commonly consumed drug has not. Miner et al published a paper using BIS to validate the use of Altered Mental Status Scale in intoxicated patients.[9] This study did not aim to determine a relationship between alcohol concentration and BIS and included patients who may have consumed other drugs. Thus, there were potentially many confounding factors that may have influenced the relationship between alcohol concentration and BIS. 1. Myles, P.S., et al., Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet, 2004. 363(9423): p. 1757-63. 2. Dahaba, A.A., Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg, 2005. 101(3): p. 765-73. 3. Ekman, A., et al., Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand, 2004. 48(1): p. 20-6. 4. Haug, E., et al., Bispectral electroencephalographic analysis of head-injured patients in the emergency department. Acad Emerg Med, 2004. 11(4): p. 349-52. 5. Ebtehaj, M., et al., Correlation between BIS and GCS in patients suffering from head injury. Ir J Med Sci, 2012. 181(1): p. 77-80. 6. Erdogan, M.A., et al., The effects of cognitive impairment on anaesthetic requirement in the elderly. Eur J Anaesthesiol, 2012. 29(7): p. 326-31. 7. Liu, J., H. Singh, and P.F. White, Electroencephalographic bispectral index correlates with intraoperative recall and depth of propofol-induced sedation. Anesth Analg, 1997. 84(1): p. 185-9. 8. Unnikrishnan, K.P., et al., Case report: alterations in bispectral index following absolute alcohol embolization in a patient with intracranial arteriovenous malformation. Can J Anaesth, 2007. 54(11): p. 908-11. 9. Miner, J.R., A. Gaetz, and M.H. Biros, The association of a decreased level of awareness and blood alcohol concentration with both agitation and sedation in intoxicated patients in the ED. Am J Emerg Med, 2007. 25(7): p. 743-8.

  • Management of Asthma with Supportive Telehealth of Respiratory function in Pregnancy (MASTERY [copyright])

    Background: Poorly controlled asthma during pregnancy may harm both the baby and the mother, causing an increased risk of pre-eclampsia, prematurity, low birth weight and perinatal mortality . More than half of pregnant women do not take their preventer medications on a regular basis before and during pregnancy leading to asthma exacerbations. Evidence shows that better asthma control will be achieved if patients are involved in self-management, including regular self-monitoring of symptoms and/or lung function. This study will examine the potential for enhanced telehealth support for asthma in pregnancy. Telehealth may provide an attractive alternative to standard medical care for pregnant women with asthma. As well as providing accessibility and flexibility for patients, other potential benefits include reduced time to access healthcare services, reduced travel costs, earlier detection of worsening asthma such as exacerbations and reduced healthcare visits/hospitalisations. However, there are only a few well conducted studies in Australia providing evidence on the applications of telehealth for any condition. Aims: To develop a telehealth program for asthma management and to trial its effectiveness in pregnant women with asthma. We hypothesise that telehealth for supporting management of asthma during pregnancy will result in better asthma control, better quality of life, better maternal and better neonatal outcomes compared to the usual care Methods: A mobile phone application (Breathe-easy [copyright]) will be developed to facilitate communication between patients and their health professionals. Patient lung function data (measured using the COPD-6[copyright] device) will be transmitted daily via a mobile phone to a central server. Patients will receive automatic feedback on their mobile phones according to an individualised algorithm. The GP/Obstetrician will be notified when an unscheduled visit and/or change in medication is needed.

  • Mindfulness-based Stress Reduction for Restless Legs Syndrome: A Single Arm Pilot Study

    The aim of this study is to investigate whether Mindfulness-based stress reduction (MBSR) can be used as an effective treatment option for people with restless legs syndrome (RLS). Specifically, the aim is to evaluate the effectiveness of the six-week MBSR group program in enhancing measures of RLS-specific quality of life, general health, sleep, RLS-specific symptom severity, depression and anxiety symptoms, and mindfulness skills. It is hypothesised that there will be a significant improvement in subjective measures of RLS symptom severity, RLS-related quality of life, general health, symptoms of psychopathology, including anxiety and depression, and subjective and objective measures of sleep, directly following the MBSR program and at three months post-intervention.

  • Altering the Rehabilitation Environment to Improve Stroke Survivor Activity (AREISSA): A Phase II Trial

    Despite higher levels of activity being associated with better stroke recovery, stroke patients on most rehabilitation units spend the majority of their day inactive and alone. In animal models, Environmental Enrichment (EE) involves organisation of the environment and provision of equipment to facilitate physical, cognitive and social activity. EE promotes rewiring of the brain after stroke and has been found to significantly enhance functional recovery. Preliminary work on the use of a human model of EE using individual (eg. iPods, & word puzzles) and communal (eg. access to interactive gaming, computer, books/newspapers & jigsaws) enrichment in a rehabilitation unit indicates it encourages stroke patients to be more active. Greater activity during rehabilitation has numerous benefits, the most important of which is achieving better functional recovery and subsequently, greater independence. Altering the Rehabilitation Environment to Improve Stroke Survivor Activity (AREISSA) is a Phase II Trial involving four rehabilitation units which seeks to determine the safety, efficacy, feasibility and patient and staff acceptability of this model of EE during stroke rehabilitation. We hypothisize that compared to stroke patients undergoing rehabilitation in non-enriched environments, patients recovering in EE will: (i) be more active at 10 days (+/- 2) post admission, and that the guidelines which accompany the EE will: (ii) be adhered to by staff, and (iii) not result in a significant increase in falls or other adverse events. Results from AREISSA will be used to inform future larger trials required to determine the effect of EE on stroke recovery and stroke survivor quality of life.

  • Assessing a new clinical resource for anorexia nervosa: Stories of recovery from anorexia

    What is the study about? Anorexia nervosa is a serious mental illness that is associated with much distress and difficulties for those living with the illness. There is still a lot we do not know about how to effectively treat anorexia nervosa. A new clinical resource has been developed for those with anorexia nervosa and subclinical anorexia. This resource contains the stories of recovery of former sufferers of the illness who have now been successfully recovered for five or more years. Adults who are eighteen years or over with anorexia nervosa or subclinical anorexia (i.e., Body Mass Index (BMI) of less than 20) are invited to take part in a study that is investigating the effectiveness of this new resource. What does the study involve? This study involves firstly completing a brief questionnaire online to assess your eligibility for the study. If eligible, the study involves completing questionnaires online, which will ask you about your current eating habits, attitudes towards eating, shape, and weight, motivational issues, and your beliefs and attitudes about recovery. You will be asked to complete these questionnaires on either two or three occasions, two weeks apart. You will also be asked to read the resource, which contains five stories of recovery from anorexia. This will be emailed to your nominated email address. After reading the materials you are then invited to give feedback on the resource.

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