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Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

6 mars 2017 mis à jour par: Nan Jiang

Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.

Type d'étude

Interventionnel

Inscription (Anticipé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510080
        • Recrutement
        • the First Affiliated Hospital of Sun Yetsen University
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.

Exclusion Criteria:

  • abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Médicament: Dexmedetomidine
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Autres noms:
  • DEX
Comparateur placebo: Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
Autre: normal saline
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Autres noms:
  • N.-É.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
urapidil consumption
Délai: the end of the 6th hour after tracheal extubation
urapidil consumption was recorded by nurses every hour
the end of the 6th hour after tracheal extubation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
urapidil consumption on POD1
Délai: the total consumption of urapidil on post-operative day 1.
urapidil consumption was recorded by nurses every hour
the total consumption of urapidil on post-operative day 1.
urapidil consumption on POD2
Délai: the total consumption of urapidil on post-operative day 2.
urapidil consumption was recorded by nurses every hour
the total consumption of urapidil on post-operative day 2.
Visual Analogue score
Délai: the end of the 6th hour after tracheal extubation
visual analogue score was measured by visual analogue scale
the end of the 6th hour after tracheal extubation
Visual Analogue score at 24th hour
Délai: the end of the 24th hour after tracheal extubation
visual analogue score was measured by visual analogue scale
the end of the 24th hour after tracheal extubation
Visual Analogue score at 48th hour
Délai: the end of the 48th hour after tracheal extubation
visual analogue score was measured by visual analogue scale
the end of the 48th hour after tracheal extubation
Quality of Recovery Score
Délai: the end of the 6th hour after tracheal extubation
Quality of Recovery Score was measured by a 15-item quality of recovery scale
the end of the 6th hour after tracheal extubation
Quality of Recovery Score at 24th hour
Délai: the end of the 24th hour after tracheal extubation
Quality of Recovery Score was measured by a 15-item quality of recovery scale
the end of the 24th hour after tracheal extubation
Quality of Recovery Score at 48th hour
Délai: the end of the 48th hour after tracheal extubation
Quality of Recovery Score was measured by a 15-item quality of recovery scale
the end of the 48th hour after tracheal extubation
Analgesics consumption
Délai: the end of the 6th hour after tracheal extubation
Analgesics consumption was recorded by nurse every hour
the end of the 6th hour after tracheal extubation
Analgesics consumption on POD1
Délai: the total consumption of urapidil on post-operative day 1.
Analgesics consumption was recorded by nurse every hour
the total consumption of urapidil on post-operative day 1.
Analgesics consumption on POD2
Délai: the total consumption of urapidil on post-operative day 2.
Analgesics consumption was recorded by nurse every hour
the total consumption of urapidil on post-operative day 2.
Bradycardia
Délai: the end of the 6th hour after tracheal extubation
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
the end of the 6th hour after tracheal extubation
Bradycardia at 24th hour
Délai: the end of the 24th hour after tracheal extubation
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
the end of the 24th hour after tracheal extubation
Bradycardia at 48th hour
Délai: the end of the 48th hour after tracheal extubation
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
the end of the 48th hour after tracheal extubation
PONV
Délai: the end of the 6th hour after tracheal extubation
post-operative nausea and vomiting (PONV) was recorded by nurse
the end of the 6th hour after tracheal extubation
PONV at 24th hour
Délai: the end of the 24th hour after tracheal extubation
post-operative nausea and vomiting (PONV) was recorded by nurse
the end of the 24th hour after tracheal extubation
PONV at 48th hour
Délai: the end of the 48th hour after tracheal extubation
post-operative nausea and vomiting (PONV) was recorded by nurse
the end of the 48th hour after tracheal extubation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nan Jiang

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2016

Achèvement primaire (Anticipé)

31 décembre 2017

Achèvement de l'étude (Anticipé)

31 décembre 2017

Dates d'inscription aux études

Première soumission

6 mars 2017

Première soumission répondant aux critères de contrôle qualité

6 mars 2017

Première publication (Réel)

9 mars 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 mars 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NJiang2016-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

the IPD will not be shared with others, since following investigations based on this trial is about to start.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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