[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643756":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":67,"collaborators":70,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient controlled propofol sedation","EXPERIMENTAL","Patient controlled propofol sedation. By pushing a button the patient will be administred a bolusdose of propofol 5 mg intravenously. There is a lock-out function of max 8 administrations per minute, ie the maximum propofol dose per minute is 40 mg.",[13],"Drug: Patient controlled analgesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard conscious sedation with midazolam and fentanyl","ACTIVE_COMPARATOR","Conscious sedation with midazolam and\u002For fentanyl administred by the endoscopy nurse. Midazolam will be given in doses of 1-2 mg intravenously. Fentanyl will be given, if needed, in doses of 0.25-0.5 mg intravenously",[19],"Drug: Standard medical treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Patient controlled analgesia","Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes\u002Fminute",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard medical treatment","Midazolam and\u002For fentanyl given intravenously as needed by endoscopy nurse",[15],[32],{"name":33,"affiliation":5,"role":34},"Richard E Marsk, MD, Docent","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+46 8 123 71956","richard.marsk@ki.se",[41,57],{"facility":42,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Endoscopy Unit, StGörans Hospital","Stockholm","Sweden","SE",{"type":47,"coordinates":48},"Point",[49,50],18.06871,59.32938,{"lat":50,"lon":49},[53],{"name":54,"role":37,"phone":55,"phoneExt":26,"email":56},"Tamaki Ichiya, MD, PhD Student","+46 8 587 010 00","tamaki.ichiya@ki.se",{"facility":58,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Endoskopicentrum, Danderyds Hospital",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},[63],{"name":64,"role":37,"phone":65,"phoneExt":26,"email":66},"Ylva Falkén, MD, PhD","+46 123 550 00","ylva.falken@regionstockholm.se",{"type":34,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Richard Marsk","Associate professor",[71,73],{"name":72,"class":6},"Danderyd Hospital",{"name":74,"class":6},"Capio Sankt Görans Hospital","100643756","phase-4-patient-controlled-propofol-sedation-versus-standard-sedation-in-advanced-therapeutic-colonoscopy-with-a-focus-on-patient-satisfaction-100643756",false,"NCT07637279","Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction","Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Therapeutic Colonoscopies","PCAPS2","Inclusion Criteria:\n\n* Scheduled for elective diagnostic colonoscopy in propofol sedation\n* Able to understand the study information and provide inform consent\n* ASA I-II\n* Able to understand and use the patient-controlled sedation device\n* Able to complete study questioneeres\n\nExclusion Criteria:\n\n* ASA \\>=III\n* Known hypersensitivity or contraindication to propofol or any excipient in the formulation.\n* Pregnancy or breastfeeding.\n* Inability to provide valid informed consent\n* Cognitive impairment, severe psychiatric illness, or other condition limiting reliable participation or questionnaire completion.\n* Inability to understand study procedures or insufficient language proficiency without available validated study support.\n* History of serious adverse reaction or complication related to sedation or anesthesia.","ALL","18 Years","90 Years",{"count":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to standard conscious sedation in advanced therapeutic endoscopy.\n\n• Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with standard conscious sedation\n\nParticipants will:\n\n* Be randomized to either sedation route.\n* Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.",[94],"Colo-rectal Polyps",[96,97,98],"Colonoscopy","Endoscopic submucosal dissection","Patient satisfaction","NOT_YET_RECRUITING","2026-06-07",{"date":102,"type":103},"2026-06-09","ACTUAL",{"date":105,"type":88},"2026-11-01",{"date":107,"type":88},"2028-11-01",{"name":5,"class":6},2]