drugset / Trial / NCT04195321

Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly

NCT04195321

Phase 4 Completed 62 enrolled Kasr El Aini Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be potentially harmful in this special group of patients. Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population. it was reported that PE improved the intraoperative hemodynamic profile in elderly patients undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α agonist) was reported to decrease cardiac output which limit its use in patients with compromised cardiac contractility; this fact makes the use of PE in elderly patients questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic activity; thus, NE is characterized by less cardiac depression compared to PE. NE was recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia. In non-obstetric population, although, NE infusion effectively maintained patients hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately evaluated in elderly population

Timeline

Start
2020-01-01
Primary completion
2020-03-26
Completion
2020-03-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Norepinephrine Other / unclassified 8 ug/ml Intravenous
Comparator Phenylephrine Small molecule 100 ug/ml Intravenous

Indications

No indication recorded.