[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642139":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":66,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient controlled propofol sedation","EXPERIMENTAL","Patients will self administer propofol by pushing a button (5 mg iv, 8 activations per minute resulting in max dose of 40 mg propofol\u002Fminute) as needed",[13],"Drug: Self administred propofol",{"label":15,"type":16,"description":17,"interventionNames":18},"Nurse assisted propofol sedation","ACTIVE_COMPARATOR","The endoscopy nurse will administer propofol in bolus doses of 10 mg iv as needed",[19],"Drug: Nurse assisted propofol sedation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Self administred propofol","Patients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination",[15],[31],{"name":32,"affiliation":5,"role":33},"Richard E Marsk, Docent","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+46 8 123 71956","richard.marsk@ki.se",[40,56],{"facility":41,"status":26,"city":42,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Endoscopy Unit, StGörans Hospital","Stockholm","Sweden","SE",{"type":46,"coordinates":47},"Point",[48,49],18.06871,59.32938,{"lat":49,"lon":48},[52],{"name":53,"role":36,"phone":54,"phoneExt":26,"email":55},"Tamaki Ichiya, MD, PhD student","+46 8 587 010 00","tamaki.ichiya@ki.se",{"facility":57,"status":26,"city":42,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Endoskopicentrum, Danderyds Hospital",{"type":46,"coordinates":59},[48,49],{"lat":49,"lon":48},[62],{"name":63,"role":36,"phone":64,"phoneExt":26,"email":65},"Ylva Falkén, MD,PhD","+46 123 550 00","ylva.falken@regionstockholm.se",{"type":33,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Richard Marsk","Associate professor","100642139","phase-4-patient-controlled-propofol-sedation-versus-nurse-assisted-propofol-sedation-in-diagnostic-colonoscopies-with-a-focus-on-patient-satisfaction-100642139",false,"NCT07653867","Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction","Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Diagnostic Colonoscopies","PCAPS1","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 quistioneeres\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":81,"type":82},135,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies.\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 nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary)\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.",[88],"Colonoscopy (Procedure)",[90,91,92],"colonoscopy","sedation","patient controlled propofol sedation","NOT_YET_RECRUITING","2026-06-16",{"date":96,"type":97},"2026-06-17","ACTUAL",{"date":99,"type":82},"2026-11-01",{"date":101,"type":82},"2028-11-01",{"name":5,"class":6},2]