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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Ahmed Abdelhamed Faress, Resident
- Telefonnummer: 01065080913
- E-post: drahmedfaress23896@gmail.com
Studera Kontakt Backup
- Namn: Fawzy Abbas Badawy, Professor
Studieorter
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-
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Sohag, Egypten
- Rekrytering
- Sohag university hospital
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Kontakt:
- Mohamed N Hamdoun, Professor
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Norepinehrine group
• NE group: norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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Experimentell: Phenylepherine group
PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.
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phenylephrine infusion at 100 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring
Tidsram: From the start of subarachnoid block until the end of surgery .
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Heart rate will be continously monitored using standar electrocardiogram monitoring.
to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.
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From the start of subarachnoid block until the end of surgery .
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of spinal anesthesia-induced hypotension
Tidsram: From the administration of spinal anesthesia until the end of the procedure.
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Defined as a decrease in mean arterial pressure (MAP) to <80% of baseline measurd by non-invasive blood pressure monitoring .
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From the administration of spinal anesthesia until the end of the procedure.
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Incidence of bradycardia
Tidsram: Throughout the intraoperative period
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Defined as heart rate ≤ 50 beats/min.
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Throughout the intraoperative period
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Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring
Tidsram: Every 5 minutes from the start of spinal anesthesia until the end of surgery.
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Monitoring the stability of blood pressure during vasopressor infusion
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Every 5 minutes from the start of spinal anesthesia until the end of surgery.
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Incidence of reactive hypertension measured by non-invasive blood pressure monitoring
Tidsram: From the start of vasopressor infusion until the end of surgery.
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Defined as mean arterial pressure (MAP) > 125% of baseline.
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From the start of vasopressor infusion until the end of surgery.
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Total intraoperative intavenous fluid
Tidsram: At the end of the surgical procedure.
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Total volume of intravenous fluids administered in milliliters
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At the end of the surgical procedure.
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Soh-Med-26-5-9MS
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