[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450845":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Pregabalin","ACTIVE_COMPARATOR","Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia",[13],"Drug: Pregabalin 150mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Group Fentanyl","Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg \u002Fkg fentanyl at induction of anesthesia",[18],"Drug: Fentanyl 100 micrograms ampoule",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pregabalin 150mg","Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Fentanyl 100 micrograms ampoule",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Ghada Mohamed Samir, MD","CONTACT","01005043691","002","dr.ghada216@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ain-Shams University","RECRUITING","Cairo","Egypt","EG",{"type":44,"coordinates":45},"Point",[46,47],31.24967,30.06263,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ghada M.Samir","Assistant Professor of Anesthesia, Intensive care and Pain Management","100450845","early-phase-1-effect-of-preoperative-oral-pregabalin-versus-intraoperative-fentanyl-on-postoperative-analgesia-100450845",false,"NCT05150795","Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia","The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study","Inclusion Criteria:\n\n* ASA physical status I\n\nExclusion Criteria:\n\n* Patients' refusal\n* use of sedatives, hypnotics, anti-psychotic or antidepressant drugs\n* history of drug\u002Falcohol abuse\n* history of chronic pain\n* daily intake of analgesics\n* history of epilepsy",true,"FEMALE","21 Years","45 Years",{"count":67,"type":68},80,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.\n\nPre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.\n\nPerioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.",[74],"Post Operative Pain, Acute",[76,77],"pregabalin","analgesia","2025-01-27",{"date":80,"type":81},"2025-01-29","ACTUAL",{"date":83,"type":81},"2022-01-01",{"date":85,"type":68},"2026-12",{"name":5,"class":6},1]