[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343846":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":82,"centralContacts":89,"locations":95,"responsibleParty":132,"collaborators":77,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":77,"enrollmentInfo":144,"targetDuration":77,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":98,"whyStopped":77,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Göteborg University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Control group: The patients receive the routine based anesthesiological treatment during bariatric surgery (Gastric By-Pass or Sleeve Gastrectomy). It consists of:\n\nGeneral anesthesia induction: TCI Remifentanil Cpt 6 ng\u002Fml\u002F Cp 3.2 ng\u002Fm, Propofol 1.5-2 mg\u002Fkg iv, Desflurane\u002FSevuflurane MAC (0.6-0.8).\n\nMaintained by Desflurane MAC (0.6-0.8) adjusted via BIS (40-60) and Remifentanil Cp 4-10 ng\u002Fml.\n\nPost-operative pain management: Oxycodone 2.5 mg iv if the pain is rated by patient NRS ≧3. Paracetamol 1 g\u002F6 h and Diclofenac 80 mg\u002F24 h.",[13,14,15,16],"Drug: Remifentanil","Drug: Desflurane","Drug: Propofol","Drug: Oxycodone",{"label":18,"type":19,"description":20,"interventionNames":21},"Intervention","EXPERIMENTAL","Induction: Dexmedetomidine 0.2 micrograms\u002Fkg\u002Fh iv 5 min+16 mcg, Esketamine 0.1mg\u002Fkg + Propofol 1.5-2 mg\u002Fkg iv, Desflurane\u002FSevuflurane MAC (0.6-0.8).\n\nMaintained by Desflurane\u002FSevuflurane MAC (0.6-0.8) BIS (40-60), Dexmedetomidine 0.2 micrograms\u002Fkg\u002Fh, Esketamine 0.1-0.3mg\u002Fkg\u002Fh och 0.1 mg\u002Fkg in case of hypertension. End of surgery, Lidocaine 1 mg\u002Fkg iv (max 4 mg\u002Fkg \u002F4 h), Midazolam 0.5mg\n\nPost-operative: Dexmedetomidine (0.1-0.2 micrograms\u002Fkg\u002Fh up to 4 h post-operative). If the pain is rated NRS ≧3: Transcutaneous Nerve Stimulation (TENS) with high intensive 40-50 mA for 1 minute, if the patient still NRS ≧3, the TENS treatment is repeated one more time. If pain NRS ≧3 after two treatments with TENS: Esketamine 0.1mg\u002Fkg iv + Lidocaine 0.5 mg\u002Fkg iv (max 4 mg\u002Fkg \u002F4 h) If pain NRS still ≧3 within 30 minutes after both TENS and Esketamine\u002FLidocaine, 2.5 mg Oxycodone iv until NRS \\\u003C 3. Perioperative and at discharge, PCC will be used for the the intervention (Phase 2 patients)",[22,23,24,25,26,14,15],"Drug: Dexmedetomidine","Behavioral: Person-centred care (PCC)","Drug: Esketamine","Drug: Lidocaine","Device: Transcutaneous Nerve Stimulation (TENS)",[28,35,42,48,54,61,67,73,78],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Dexmedetomidine","The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:",[18],[34],"Dexdor",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BEHAVIORAL","Person-centred care (PCC)","The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge. This will be part of patients in Phase 2",[18],[41],"Phase 2",{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Esketamine","The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:",[18],[47],"Ketanest",{"type":29,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Lidocaine","The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment.",[18],[53],"Xylocaine",{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DEVICE","Transcutaneous Nerve Stimulation (TENS)","The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.",[18],[60],"TENS",{"type":29,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Remifentanil","The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.",[9],[66],"Ultiva",{"type":29,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Desflurane","The patient receives general anesthesia with Desflurane\u002F or Sevoflurane as the routine volatile anesthetic during general anesthesia",[9,18],[72],"Desfluran",{"type":29,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Propofol","The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia",[9,18],null,{"type":29,"name":79,"description":80,"armGroupLabels":81,"otherNames":77},"Oxycodone","The control group receives Oxycodone as the routine pain management drug post-operative.",[9],[83,86],{"name":84,"affiliation":5,"role":85},"Sven-Egron Thörn, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":87,"affiliation":5,"role":88},"Axel Wolf, RN, PhD, Professor","STUDY_CHAIR",[90],{"name":91,"role":92,"phone":93,"phoneExt":77,"email":94},"Axel Wolf, RN, PhD","CONTACT","+46709355364","axel.wolf@gu.se",[96,115],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Lindesberg Hospital","RECRUITING","Lindesberg","Region Örebro","711 82","Sweden","SE",{"type":105,"coordinates":106},"Point",[107,108],15.2304,59.59202,{"lat":108,"lon":107},[111],{"name":112,"role":92,"phone":113,"phoneExt":77,"email":114},"Henrik Öhström, MD","+4619-602 03 56‬","henrik.ohrstrom@regionorebrolan.se",{"facility":116,"status":98,"city":117,"state":118,"zip":119,"country":102,"countryCode":103,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Sahlgrenska University hospital\u002F Östra hopsital","Gothenburg","VG","41678",{"type":105,"coordinates":121},[122,123],11.96679,57.70716,{"lat":123,"lon":122},[126,128],{"name":127,"role":92,"phone":93,"phoneExt":77,"email":94},"Axel Wolf, RN\u002FMBA\u002FPhD",{"name":129,"role":92,"phone":130,"phoneExt":77,"email":131},"Sven-Egron Thörn, MD\u002FPhD","+46 31-343 49 03","sven-egron.thorn@vgregion.se",{"type":133,"investigatorFullName":77,"investigatorTitle":77,"investigatorAffiliation":77,"oldNameTitle":77,"oldOrganization":77},"SPONSOR","100343846","effects-of-an-opioid-freesparing-care-pathway-for-patients-undergoing-obesity-surgery-100343846",false,"NCT03756961","Effects of an Opioid Free\u002FSparing Care Pathway for Patients Undergoing Obesity Surgery","Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery","OS-PCC","Inclusion Criteria:\n\n-Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.\n\nExclusion Criteria:\n\n* ASA\\> III\n* Cardiovascular disease with bradycardia (\\\u003C50 bpm)\n* Serious liver disease failure\n* Insufficient knowledge of the Swedish language\n* Serious untreated psychiatric disease\n* Neurocognitive dysfunction\n* Pregnancy\n* Women of childbearing age without contraception\n* Malignant disease with expected short survival\n* Patients treated with opioids for chronic pain\n* Substance abuse\n* Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine\n* Pacemaker or ICD\n* Inability to fill in questionnaires\n* Decline participation,","ALL","18 Years",{"count":145,"type":146},220,"ESTIMATED","INTERVENTIONAL",[149],"NA","The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing\u002F opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy.\n\nThe overall aim is to evaluate the short-, medium- and long-term effects of opioid-free care pathways with or without person-centred care compared to conventional opioid-based treatment in patients undergoing obesity surgery.\n\nSpecific aims\n\n1. Determine the effects of opioid-free care with or without person-centred care compared with conventional opioid-based general anaesthesia on the cognitive and physical quality of recovery after surgery up to 24 months after surgery (short-term: postoperative to discharge, medium-term: 14 days, 3 months, long-term: 6 months, 12 months and 24 months).\n2. Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.\n3. Map the impact of opioid-free anaesthesia (with and without person-centred care) on the usage of opioids up to 24 months after hospital discharge.\n4. Explore the patients' experience of quality of life, economic evaluations, self-efficacy and recovery after surgery in opioid-free care with or without person-centred care during the first year post-surgery.\n\nThe aims will be evaluated by a prospective, randomized, non-blinded, non-commercial multi-centre study (Nov 2018-Dec 2022) approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).",[152,153],"Obesity","Pain, Postoperative",[155,156,157,158,159,160,60,161],"opioids","bariatric surgery","anesthesia","opioid-free","person-centred care","recovery","pain","2026-01-02",{"date":164,"type":165},"2026-01-07","ACTUAL",{"date":167,"type":165},"2019-05-01",{"date":169,"type":146},"2029-12-31",{"name":5,"class":6},2]