Sohag university hospital
Sohag, Egypt
Location status: Recruiting
Location contact
Mohamed N Hamdoun, Professor
CONTACT
Recruiting
NCT Number: NCT07662408
Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
60 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
norepinephrine
Drugnorepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
Phenylephrine
Drugphenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
Primary outcomes
-
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 .
Heart rate will be continously monitored using standar electrocardiogram monitoring. to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.
Secondary outcomes
-
Incidence of spinal anesthesia-induced hypotension
Time frame: From the administration of spinal anesthesia until the end of the procedure.
Defined as a decrease in mean arterial pressure (MAP) to <80% of baseline measurd by non-invasive blood pressure monitoring .
-
Incidence of bradycardia
Time frame: Throughout the intraoperative period
Defined as heart rate ≤ 50 beats/min.
-
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.
Monitoring the stability of blood pressure during vasopressor infusion
-
Incidence of reactive hypertension measured by non-invasive blood pressure monitoring
Time frame: From the start of vasopressor infusion until the end of surgery.
Defined as mean arterial pressure (MAP) > 125% of baseline.
-
Total intraoperative intavenous fluid
Time frame: At the end of the surgical procedure.
Total volume of intravenous fluids administered in milliliters
Study contacts
Contact information is provided by the study sponsor or research team.
Ahmed Abdelhamed Faress, Resident
CONTACT
Fawzy Abbas Badawy, Professor
CONTACT
Sponsors and collaborators
Lead sponsor
Sohag University
Other
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 23, 2026
- Registry last updated
- Jun 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.