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

NCT07662408 | Recruiting Phase 4

• 1 other identifier: Soh-Med-26-5-9MS
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia; Orthopedic Hip Sugery in Eldely Patients

Keywords

Norepinehrine versus phenylepherine infusion in management of post-spinal hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of spinal anesthesia-induced hypotension

  From the administration of spinal anesthesia until the end of the procedure.

• Incidence of bradycardia

  Throughout the intraoperative period

• Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring

  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

  From the start of vasopressor infusion until the end of surgery.

• Total intraoperative intavenous fluid

  At the end of the surgical procedure.

Study Arms (2)

Norepinehrine group

EXPERIMENTAL

• NE group: norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

Drug: Norepinephrine

Phenylepherine group

EXPERIMENTAL

PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.

Drug: Phenylephrine

Interventions

Norepinephrine DRUG

norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

Norepinehrine group

Phenylephrine DRUG

phenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

Phenylepherine group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient refusal.
• Contraindications to subarachnoid block.
• Severe cardiac disease.
• Uncontrolled hypertension.
• Allergy to study drugs.
• Emergency surgery.
• Monoamine oxidase inhibitor use.
• Cognitive impairment preventing informed consent.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

Norepinephrine; Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ahmed Abdelhamed Faress, Resident

CONTACT

01065080913; drahmedfaress23896@gmail.com

Fawzy Abbas Badawy, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anaesthesia. Surgical ICU and pain managment at sohag university hospital

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 23, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

EG (1)