Orthopedic Hip Sugery in Eldely Patients, Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia
Conditions
Keywords
Norepinehrine versus phenylepherine infusion in management of post-spinal hypotension
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.
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
DRUGNorepinephrine
norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
DRUGPhenylephrine
phenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of spinal anesthesia-induced hypotension | 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 | Throughout the intraoperative period | Defined as heart rate ≤ 50 beats/min. |
| 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. | Monitoring the stability of blood pressure during vasopressor infusion |
| Incidence of reactive hypertension measured by non-invasive blood pressure monitoring | From the start of vasopressor infusion until the end of surgery. | Defined as mean arterial pressure (MAP) \> 125% of baseline. |
| Total intraoperative intavenous fluid | At the end of the surgical procedure. | Total volume of intravenous fluids administered in milliliters |
Countries
Egypt
Contacts
CONTACTAhmed Abdelhamed Faress, Resident
CONTACTFawzy Abbas Badawy, Professor
Outcome results
None listed