Menu
Recruiting NCT07662408

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

Phase IV Interventional Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia Orthopedic Hip Sugery in Eldely Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norepinephrine, Phenylephrine.
Who it may be relevant to
Registry conditions: Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia, Orthopedic Hip Sugery in Eldely Patients. Basic parameters: 60 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug Norepinephrine
    norepinephrine infusion at 8 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.

Primary outcome measures

  • Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring [Time frame: From the start of subarachnoid block until the end of surgery .]
Secondary outcome measures (5)
  • Incidence of spinal anesthesia-induced hypotension [Time frame: From the administration of spinal anesthesia until the end of the procedure.]
  • Incidence of bradycardia [Time frame: Throughout the intraoperative period]
  • Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring [Time frame: 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 [Time frame: From the start of vasopressor infusion until the end of surgery.]
  • Total intraoperative intavenous fluid [Time frame: At the end of the surgical procedure.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Sohag university hospital — Sohag

Identifiers

NCT: NCT07662408 · Soh-Med-26-5-9MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗