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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ahmed Abdelhamed Faress, Resident
- Numéro de téléphone: 01065080913
- E-mail: drahmedfaress23896@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Fawzy Abbas Badawy, Professor
Lieux d'étude
-
-
-
Sohag, Egypte
- Recrutement
- Sohag university hospital
-
Contact:
- Mohamed N Hamdoun, Professor
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Norepinehrine group
• NE group: norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
|
Expérimental: Phenylepherine group
PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.
|
phenylephrine infusion at 100 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring
Délai: 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.
|
From the start of subarachnoid block until the end of surgery .
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of spinal anesthesia-induced hypotension
Délai: 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 .
|
From the administration of spinal anesthesia until the end of the procedure.
|
|
Incidence of bradycardia
Délai: Throughout the intraoperative period
|
Defined as heart rate ≤ 50 beats/min.
|
Throughout the intraoperative period
|
|
Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring
Délai: Every 5 minutes from the start of spinal anesthesia until the end of surgery.
|
Monitoring the stability of blood pressure during vasopressor infusion
|
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
Délai: From the start of vasopressor infusion until the end of surgery.
|
Defined as mean arterial pressure (MAP) > 125% of baseline.
|
From the start of vasopressor infusion until the end of surgery.
|
|
Total intraoperative intavenous fluid
Délai: At the end of the surgical procedure.
|
Total volume of intravenous fluids administered in milliliters
|
At the end of the surgical procedure.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Soh-Med-26-5-9MS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .