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A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.

Not Applicable
Completed
Conditions
LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients
Interventions
Device: Laryngeal mask airway
Drug: Magensium sulphate
Other: Control group (closure of anesthetics)
Registration Number
NCT03406403
Lead Sponsor
Cairo University
Brief Summary

To evaluate the efficacy of replacement of ETT with LMA and administration of Magnesium sulphate at the end of the surgery in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  1. ASA physical status I, II.
  2. Ages between 18 and 60 years.
  3. Body mass index (BMI) < 30.
  4. Elective surgery
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Exclusion Criteria
  1. Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.
  2. Patients have any degree of disturbed conscious level.
  3. Ages <18 or >60 years.
  4. BMI >30.
  5. Patients have history of allergy to Magnesium sulphate.
  6. Patients have uncontrolled hypertension during preoperative assessment.
  7. Patients have risk of aspiration (eg. hiatus hernia)
  8. Patients have difficult airway management during intubation with direct laryngoscope or time of intubation >30 seconds.
  9. Failed ventilation with LMA.
  10. Emergency surgery.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Laryngeal mask airway groupLaryngeal mask airway20 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.
Laryngeal mask airway groupControl group (closure of anesthetics)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.
Magensium sulphate groupLaryngeal mask airway20 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
Magensium sulphate groupMagensium sulphate20 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
Magensium sulphate groupControl group (closure of anesthetics)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
Control group (closure of anesthetics)Laryngeal mask airway20 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.
Control group (closure of anesthetics)Magensium sulphate20 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.
Control group (closure of anesthetics)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.
Laryngeal mask airway groupMagensium sulphate20 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.
Primary Outcome Measures
NameTimeMethod
Mean arterial blood presure5 minutes from closure of anesthetics until 15 minutes after extubation

Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.

Secondary Outcome Measures
NameTimeMethod
Intracranial pressure Measurement1 and 10 minutes after extubation.

Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.

Quality of extubationTime Onset of cough immediately after extubation

Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale

Level of consciousness5 and 15 minutes after extubation

consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices

End of surgery and extubationintraoperative

Time interval between end of surgery and extubation in each group

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed

🇪🇬

Cairo, Egypt

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