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The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

ABSTRACT: BACKGROUND:In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS:This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women >?18?years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5?cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6?weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION:This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION:Dutch trial register, number NTR5357 . Registered 11th of August 2015.

SUBMITTER: van der Meulen JF

PROVIDER: S-EPMC6431064 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

van der Meulen Julia F JF Bongers Marlies Y MY Coppus Sjors F P J SFPJ Bosmans Judith E JE Maessen José M C JMC Oude Rengerink Katrien K Overdijk Lucilla E LE Radder Celine M CM van der Voet Lucet F LF Smeets Nicol A C NAC van Vliet Huib A A M HAAM Hehenkamp Wouter J K WJK Manger Arentje P AP Spaans Wilbert A WA Bakkum Erica A EA Horrée Nicole N Briët Justine M JM van der Steeg Jan Willem JW Kok Helen S HS

BMC women's health 20190322 1

<h4>Background</h4>In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol ( ...[more]

PMID: 30902087

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Project description:BackgroundProcedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO(2)] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes.Methods/designElectronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable.DiscussionThis review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.Systematic review registrationPROSPERO CRD42015017251.

Project description:BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237.

Project description:Procedural sedation and analgesia outside the operating theater have become standard care in managing pain and anxiety in children undergoing diagnostic and therapeutic procedures. The objectives of this study are to describe the current pediatric procedural sedation and analgesia practice patterns in European emergency departments, to perform a needs assessment-like analysis, and to identify barriers to implementation. A survey study of European emergency departments treating children was conducted. Through a lead research coordinator identified through the Research in European Pediatric Emergency Medicine (REPEM) network for each of the participating countries, a 30-question questionnaire was sent, targeting senior physicians at each site. Descriptive statistics were performed. One hundred and seventy-one sites participated, treating approximately 5 million children/year and representing 19 countries, with a response rate of 89%. Of the procedural sedation and analgesia medications, midazolam (100%) and ketamine (91%) were available to most children, whereas propofol (67%), nitrous oxide (56%), intranasal fentanyl (47%), and chloral hydrate (42%) were less frequent. Children were sedated by general pediatricians in 82% of cases. Safety and monitoring guidelines were common (74%), but pre-procedural checklists (51%) and capnography (46%) less available. In 37% of the sites, the entire staff performing procedural sedation and analgesia were certified in pediatric advanced life support. Pediatric emergency medicine was a board-certified specialty in 3/19 countries. Physician (73%) and nursing (72%) shortages and lack of physical space (69%) were commonly reported as barriers to procedural sedation and analgesia. Nurse-directed triage protocols were in place in 52% of the sites, mostly for paracetamol (99%) and ibuprofen (91%). Tissue adhesive for laceration repair was available to 91% of children, while topical anesthetics for intravenous catheterization was available to 55%. Access to child life specialists (13%) and hypnosis (12%) was rare.Conclusion: Procedural sedation and analgesia are prevalent in European emergency departments, but some sedation agents and topical anesthetics are not widely available. Guidelines are common but further safety nets, nurse-directed triage analgesia, and nonpharmacologic support to procedural sedation and analgesia are lacking. Barriers to implementation include availability of sedation agents, staff shortage, and lack of space. What is Known: • Effective and prompt analgesia, anxiolysis, and sedation (PSA) outside the operating theatre have become standard in managing pain and anxiety in children undergoing painful or anxiogenic diagnostic and therapeutic procedures. • We searched PubMed up to September 15, 2020, without any date limits or language restrictions, using different combinations of the MeSH terms "pediatrics," "hypnotics and sedatives," "conscious sedation," and "ambulatory surgical procedures" and the non-MeSH term "procedural sedation" and found no reports describing the current practice of pediatric PSA in Europe. What is New: • This study is, to the best of our knowledge, the first to shed light on the pediatric PSA practice in European EDs and uncovers important gaps in several domains, notably availability of sedation medications and topical anesthetics, safety aspects such as PSA provider training, availability of nonpharmacologic support to PSA, and high impact interventions such as nurse-directed triage analgesia. • Other identified barriers to PSA implementation include staff shortage, control of sedation medications by specialists outside the emergency department, and lack of space.

Dataset Information

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

Publications

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

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