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

Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia; Orthopedic Hip Sugery in Eldely Patients
• Intervention / Treatment: Drug: Norepinephrine; Drug: Phenylephrine

Detailed Description

Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing orthopedic hip surgery. Age-related physiological changes, impaired autonomic responses, and reduced cardiovascular reserve increase susceptibility to hypotension after subarachnoid block, which may result in organ hypoperfusion, myocardial ischemia, nausea, vomiting, and increased perioperative morbidity.

Phenylephrine is traditionally used for prevention and treatment of spinal anesthesia-induced hypotension because of its potent alpha-adrenergic vasoconstrictive effect. However, its use may be associated with reflex bradycardia and reduction in cardiac output. Norepinephrine, which possesses both alpha-adrenergic and mild beta-adrenergic activity, may provide better maintenance of heart rate and cardiac output while effectively preserving blood pressure.

This prospective randomized double-blinded clinical trial will be conducted at the Department of Anesthesia, Intensive Care and Pain Management, Sohag University Hospitals, after approval from the Institutional Ethics Committee. Elderly patients aged 60 years or older, classified as ASA physical status I-III and scheduled for elective orthopedic hip surgery under spinal anesthesia, will be enrolled after obtaining written informed consent.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Abdelhamed Faress, Resident; Phone Number: 01065080913; Email: drahmedfaress23896@gmail.com
• Study Contact Backup: Name: Fawzy Abbas Badawy, Professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag university hospital
    • Contact: Mohamed N Hamdoun, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 60 years or older.
2. ASA physical status I-III.
3. Scheduled for elective hip surgery under subarachnoid block.
4. Willing to provide written informed consent.

Exclusion Criteria:

1. Patient refusal.
2. Contraindications to subarachnoid block.
3. Severe cardiac disease.
4. Uncontrolled hypertension.
5. Allergy to study drugs.
6. Emergency surgery.
7. Monoamine oxidase inhibitor use.
8. Cognitive impairment preventing informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norepinehrine group; • NE group: norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.	Drug: Norepinephrine; norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
Experimental: Phenylepherine group; PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.	Drug: Phenylephrine; phenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring	Heart rate will be continously monitored using standar electrocardiogram monitoring. to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.	From the start of subarachnoid block until the end of surgery .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of spinal anesthesia-induced hypotension	Defined as a decrease in mean arterial pressure (MAP) to <80% of baseline measurd by non-invasive blood pressure monitoring .	From the administration of spinal anesthesia until the end of the procedure.
Incidence of bradycardia	Defined as heart rate ≤ 50 beats/min.	Throughout the intraoperative period
Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring	Monitoring the stability of blood pressure during vasopressor infusion	Every 5 minutes from the start of spinal anesthesia until the end of surgery.
Incidence of reactive hypertension measured by non-invasive blood pressure monitoring	Defined as mean arterial pressure (MAP) > 125% of baseline.	From the start of vasopressor infusion until the end of surgery.
Total intraoperative intavenous fluid	Total volume of intravenous fluids administered in milliliters	At the end of the surgical procedure.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 14, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Norepinehrine versus phenylepherine infusion in management of post-spinal hypotension
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Norepinephrine; Phenylephrine
• Other Study ID Numbers: Soh-Med-26-5-9MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No