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ED50/ED90 of Phenylephrine Infusion for Preventing Spinal Anesthesia-Induced Hypotension: Supine vs Left-Tilt 15°

StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-20
View on ClinicalTrials.gov ↗
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/kg/min; 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 \< 80% of baseline or \< 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.
Trial Details
NCT Number NCT07824713
Lead Sponsor Peking University People's Hospital
Collaborators: XuZhouHeJia hospital
Conditions Hypotension After Spinal Anesthesia
Enrollment 200 participants
Start Date 2026-09-20
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-17