drugset / Trial / NCT07662408

Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension

NCT07662408

Phase 4 Recruiting 62 enrolled Sohag University
RandomizedParallel-groupDouble-blindPrevention

Summary

This prospective randomized double-blinded clinical trial aims to compare the efficacy and hemodynamic effects of prophylactic norepinephrine infusion versus phenylephrine infusion for prevention of spinal anesthesia-induced hypotension in elderly patients undergoing elective orthopedic hip surgery under subarachnoid block. Sixty-two patients aged 60 years or older will be randomly assigned into two equal groups to receive either norepinephrine infusion (8 µg/min) or phenylephrine infusion (100 µg/min) immediately after spinal anesthesia. The primary outcome is the mean heart rate during vasopressor infusion, while secondary outcomes include incidence of hypotension, severe hypotension, bradycardia, reactive hypertension, intraoperative fluid requirements, blood loss, transfusion requirements, and postoperative nausea and vomiting. Hemodynamic parameters will be monitored throughout surgery to evaluate the safety and effectiveness of both vasopressor strategies.

Timeline

Start
2026-05-22
Primary completion
2027-03-14
Completion
2027-03-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Norepinephrine Other / unclassified 8 ug
Subject Phenylephrine Small molecule 100 ug

Indications

No indication recorded.