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- Essai clinique NCT03406403
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Rapid recovery from neuroanesthesia and early neurological examination are desirable in most cases.(1)Although, Systemic and cerebral hemodynamic changes caused by extubation and emergence from anesthesia may endanger neurosurgical patients and increase the risk of postoperative intracranial hemorrhage and cerebral edema and may even result in the requirement of reoperation.(2) During this phase, heart rate and arterial blood pressure increase leading to increases in cerebral blood flow and intracranial pressure.(3) Some studies have reported such hemodynamic effects in up to 50% of patients after supratentorial craniotomy.(4,5) Replacing the endotracheal tube (ETT) with laryngeal mask airway (LMA) prior to emergence from anesthesia is safe and effectively reduces the cardiovascular response.(6) The potential protective benefit of this approach has not yet been demonstrated for awakening neurosurgery patients, however.
Magnesium is the forth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme systems.(7) Magnesium sulphate inhibits catecholamines release from adrenergic nerve terminals and from adrenal medulla, through blocking N-type of Ca-channel at peripheral sympathetic nerve ending so it is used to decrease the adverse cardiovascular effects during larygeoscopy and endotracheal intubation.(8) But its role in attenuating stress response during extubation is not well studied and need more research.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte, 11451
- Ahmed Abdalla Mohamed
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ASA physical status I, II.
- Ages between 18 and 60 years.
- Body mass index (BMI) < 30.
- Elective surgery
Exclusion Criteria:
- Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.
- Patients have any degree of disturbed conscious level.
- Ages <18 or >60 years.
- BMI >30.
- Patients have history of allergy to Magnesium sulphate.
- Patients have uncontrolled hypertension during preoperative assessment.
- Patients have risk of aspiration (eg. hiatus hernia)
- Patients have difficult airway management during intubation with direct laryngoscope or time of intubation >30 seconds.
- Failed ventilation with LMA.
- Emergency surgery.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Laryngeal mask airway group
20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.
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After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
|
Comparateur actif: Magensium sulphate group
20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient
|
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
|
Comparateur actif: Control group (closure of anesthetics)
20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.
|
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean arterial blood presure
Délai: 5 minutes from closure of anesthetics until 15 minutes after extubation
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Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.
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5 minutes from closure of anesthetics until 15 minutes after extubation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Intracranial pressure Measurement
Délai: 1 and 10 minutes after extubation.
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Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.
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1 and 10 minutes after extubation.
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Quality of extubation
Délai: Time Onset of cough immediately after extubation
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Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
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Time Onset of cough immediately after extubation
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Level of consciousness
Délai: 5 and 15 minutes after extubation
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consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices
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5 and 15 minutes after extubation
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End of surgery and extubation
Délai: intraoperative
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Time interval between end of surgery and extubation in each group
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intraoperative
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hamed Fathy, M.S, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Tumeurs
- Tumeurs par site
- Tumeurs cérébrales
- Tumeurs du système nerveux central
- Tumeurs du système nerveux
- Tumeurs supratentorielles
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Anesthésiques
Autres numéros d'identification d'étude
- N-102-2017
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
produit fabriqué et exporté des États-Unis.
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