[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656433":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":20,"studyPopulation":20,"armGroups":43,"interventions":79,"overallOfficials":20,"centralContacts":85,"locations":91,"responsibleParty":105,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":20,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":20,"enrollmentInfo":122,"targetDuration":20,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":135,"whyStopped":20,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant","Hypotension defined as systolic blood pressure \\\u003C 80% of baseline (measured in the assigned study position) or \\\u003C 90 mmHg","From completion of spinal anesthesia to fetal delivery",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Umbilical artery and umbilical vein blood gas values","Umbilical artery and umbilical vein blood gas values (pH, PCO2, PO2, base excess, lactate)","At delivery",{"measure":19,"description":20,"timeFrame":21},"Apgar scores at 1 and 5 minutes after delivery",null,"From fetal delivery to 5 minutes after delivery",{"measure":23,"description":20,"timeFrame":24},"Time to first rescue vasopressor","From completion of intrathecal injection to delivery",{"measure":26,"description":20,"timeFrame":27},"Serial systolic blood pressure values within 12 minutes after intrathecal injection","From completion of spinal anesthesia to 12 minutes after completion of spinal anesthesia",{"measure":29,"description":30,"timeFrame":24},"Incidence of hypertension before delivery","Incidence of hypertension (systolic blood pressure ≥ 120% of baseline) before delivery",{"allocation":32,"interventionModel":33,"interventionModelDescription":20,"primaryPurpose":34,"observationalModel":20,"timePerspective":20,"maskingInfo":35},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":36,"maskingDescription":37,"whoMasked":38},"QUADRUPLE","Position allocation was open label; rate allocation was masked by concentration blinding (identical pump rate 0.6 mL\u002Fkg\u002Fh; solution concentrations 20\u002F40\u002F60\u002F80 μg\u002FmL prepared in identical syringes)",[39,40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50,54,58,62,67,71,75],{"label":45,"type":46,"description":47,"interventionNames":48},"Supine Position - Phenylephrine 0.2 μg\u002Fkg\u002Fmin","EXPERIMENTAL","Participants in the supine position (maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg\u002Fkg\u002Fmin (pump rate 0.6 mL\u002Fkg\u002Fh, concentration-blinded solution 20 μg\u002FmL) from completion of spinal anesthesia until delivery.",[49],"Drug: Phenylephrine hydrochloride infusion",{"label":51,"type":46,"description":52,"interventionNames":53},"Supine Position - Phenylephrine 0.4 μg\u002Fkg\u002Fmin","Supine position as Arm 1; phenylephrine infusion 0.4 μg\u002Fkg\u002Fmin (concentration-blinded solution 40 μg\u002FmL).",[49],{"label":55,"type":46,"description":56,"interventionNames":57},"Supine Position - Phenylephrine 0.6 μg\u002Fkg\u002Fmin","Supine position as Arm 1; phenylephrine infusion 0.6 μg\u002Fkg\u002Fmin (concentration-blinded solution 60 μg\u002FmL).",[49],{"label":59,"type":46,"description":60,"interventionNames":61},"Supine Position - Phenylephrine 0.8 μg\u002Fkg\u002Fmin","Supine position as Arm 1; phenylephrine infusion 0.8 μg\u002Fkg\u002Fmin (concentration-blinded solution 80 μg\u002FmL).",[49],{"label":63,"type":64,"description":65,"interventionNames":66},"Left-Tilt 15° - Phenylephrine 0.2 μg\u002Fkg\u002Fmin","ACTIVE_COMPARATOR","Participants in the left-lateral-tilt 15° position (sponge wedge 7.5 × 28 × 50 cm under the thoracolumbar region, maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg\u002Fkg\u002Fmin (pump rate 0.6 mL\u002Fkg\u002Fh, concentration-blinded solution 20 μg\u002FmL).",[49],{"label":68,"type":46,"description":69,"interventionNames":70},"Left-Tilt 15° - Phenylephrine 0.4 μg\u002Fkg\u002Fmin","Left-tilt 15° position as Arm 5; phenylephrine infusion 0.4 μg\u002Fkg\u002Fmin (concentration-blinded solution 40 μg\u002FmL).",[49],{"label":72,"type":64,"description":73,"interventionNames":74},"Left-Tilt 15° - Phenylephrine 0.6 μg\u002Fkg\u002Fmin","Left-tilt 15° position as Arm 5; phenylephrine infusion 0.6 μg\u002Fkg\u002Fmin (concentration-blinded solution 60 μg\u002FmL).",[49],{"label":76,"type":64,"description":77,"interventionNames":78},"Left-Tilt 15° - Phenylephrine 0.8 μg\u002Fkg\u002Fmin","Left-tilt 15° position as Arm 5; phenylephrine infusion 0.8 μg\u002Fkg\u002Fmin (concentration-blinded solution 80 μg\u002FmL).",[49],[80],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":20},"DRUG","Phenylephrine hydrochloride infusion","Prophylactic fixed-rate IV infusion (pump rate 0.6 mL\u002Fkg\u002Fh, concentration-blinded), from completion of spinal anesthesia until delivery",[63,68,72,76,45,51,55,59],[86],{"name":87,"role":88,"phone":89,"phoneExt":20,"email":90},"Feng Feng, Dr.","CONTACT","13601083503","doc_yifeng@163.com",[92],{"facility":93,"status":20,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":20},"Department of Anesthesiology，Xuzhou HeJia Hospital, Xuzhou, Jiangsu, China","Xuzhou","Jiangsu","221000","China","CN",{"type":100,"coordinates":101},"Point",[102,103],117.28386,34.20442,{"lat":103,"lon":102},{"type":106,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Yi Feng, MD","Director of Anesthesiology",[110],{"name":111,"class":112},"XuZhouHeJia hospital","UNKNOWN","100656433","phase-4-ed50ed90-of-phenylephrine-infusion-for-preventing-spinal-anesthesia-induced-hypotension-supine-vs-left-tilt-15-100656433",false,"NCT07824713","ED50\u002FED90 of Phenylephrine Infusion for Preventing Spinal Anesthesia-Induced Hypotension: Supine vs Left-Tilt 15°","Determination of the ED50 and ED90 of Prophylactic Phenylephrine Infusion for the Prevention of Spinal Anesthesia-Induced Hypotension During Elective Cesarean Delivery in the Supine and Left-Lateral-Tilt 15° Positions: A Randomized, Concentration-Blinded, Parallel-Group Dose-Response Study","Inclusion Criteria:\n\n1. Singleton term pregnancy scheduled for elective cesarean delivery\n2. Height 150-180 cm\n3. ASA physical status II-III\n4. Body mass index \\\u003C 35 kg\u002Fm2\n\nExclusion Criteria:\n\n1. Transverse lie or suspected macrosomia\n2. Uterine abnormalities (e.g., large uterine fibroids, bicornuate uterus)\n3. Polyhydramnios\n4. Ruptured membranes or oligohydramnios\n5. Fetal growth restriction\n6. Gestational or pregestational hypertension, diabetes mellitus, or preeclampsia\n7. Diseases associated with autonomic neuropathy (e.g., diabetes mellitus \\> 10 years) or renal failure\n8. Contraindications to spinal anesthesia\n9. Refusal to provide written informed consent-","FEMALE","18 Years",{"count":123,"type":124},200,"ESTIMATED","INTERVENTIONAL",[127],"PHASE4","The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Two hundred parturients with singleton term pregnancies will be randomized 1:1 to the supine group or the left-tilt 15° group, and within each position 1:1:1:1 to one of four fixed phenylephrine infusion rates (0.2, 0.4, 0.6, or 0.8 μg\u002Fkg\u002Fmin; 25 per group), with the rate allocation masked by concentration blinding (identical pump rate, different solution concentrations). Spinal anesthesia consists of hyperbaric bupivacaine 12 mg plus morphine 0.15 mg. The primary outcome is the incidence of hypotension (systolic blood pressure \\\u003C 80% of baseline or \\\u003C 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.",[130],"Hypotension After Spinal Anesthesia",[132,133,134],"Hypotension","Cesarean Delivery","Phenylephrine","NOT_YET_RECRUITING","2026-09-16",{"date":138,"type":139},"2026-09-17","ACTUAL",{"date":141,"type":124},"2026-09-20",{"date":143,"type":124},"2027-01-31",{"name":5,"class":6},1]