- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03406403
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Cairo, Egypten, 11451
- Ahmed Abdalla Mohamed
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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
|
Aktiv komparator: 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
|
Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean arterial blood presure
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Intracranial pressure Measurement
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Hamed Fathy, M.S, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer i hjärnan
- Neoplasmer i centrala nervsystemet
- Neoplasmer i nervsystemet
- Supratentoriella neoplasmer
- Läkemedels fysiologiska effekter
- Depressiva medel i centrala nervsystemet
- Bedövningsmedel
Andra studie-ID-nummer
- N-102-2017
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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