Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection
The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.
Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.
The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.
Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Laila Elahwal, MD
- Numéro de téléphone: +20 1018484319
- E-mail: Lailaelahwal@gmail.com
Lieux d'étude
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ElGharbia
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Tanta, ElGharbia, Egypte, 31511
- Recrutement
- Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
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Contact:
- Laila Elahwal, MD
- Numéro de téléphone: +20 1018484319
- E-mail: Lailaelahwal@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Cases aged between 50 and 70 years
- Having class I or II according to the American society of anesthesiologists (ASA)
Exclusion Criteria:
- Cases with heart block
- Dysrhythmia
- Contraindications for spinal anesthesia
- Known allergy to the study medications
- Classified as ASA class > II
- Alpha 2 agonist or antagonist therapy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Control group
Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.
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The cases will be subjected to spinal anesthesia with a 3 ml volume (2.5 ml of hyperbaric bupivacaine 10 mg in addition to 0.5 normal saline).
50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
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Expérimental: Intrathecal group
Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.
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The cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg in the saline component.
50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
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Expérimental: Intravenous group
Cases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose).
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The intravenous group will receive 2.5 ml of hyperbaric bupivacaine (10 mg), in addition to intravenous dexmedetomidine, which will be started at 1 μg/kg loading dose diluted in 50 ml saline administered within 10 min, followed by maintenance at a 0.4 μg/kg/h dose diluted in 200 ml saline till the end of the procedure.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time to first analgesic request
Délai: 24 hours postoperatively
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Time to first analgesic request will be recorded
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24 hours postoperatively
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The onset of sensory
Délai: 24 hours Postoperatively
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Time to reach T7 sensory block will be recorded
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24 hours Postoperatively
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The degree of motor block
Délai: 24 hours Postoperatively
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The degree of motor block will be assessed using the modified Bromage Score.
Grade 0 No motor block Grade 1 Inability to raise extended leg, able to move knees and feet Grade 2 Inability to raise extended leg and move knee, able to move feet Grade 3 Complete motor block of the lower limbs.
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24 hours Postoperatively
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Sedation level
Délai: Intraoperativley
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Patients level of sedation will be assessed via Ramsay sedation score.
This score is numbered from 1 to 6, based on patient responsiveness.
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Intraoperativley
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Total analgesic requirements
Délai: 48 hours Postoperatively
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Total analgesic requirements will be recorded
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48 hours Postoperatively
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The incidence of side effects
Délai: 48 hours Postoperatively
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The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..
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48 hours Postoperatively
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- 34141/9/20
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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