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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.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03406403
Enrollment
60
Registered
2018-01-23
Start date
2018-01-19
Completion date
2018-06-01
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients

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.

Interventions

DEVICELaryngeal mask airway

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

DRUGMagensium sulphate

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

OTHERControl group (closure of anesthetics)

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

Sponsors

Mohamed, Ahmed A., M.D.
CollaboratorINDIV
Tarek Ahmed Radwan
CollaboratorUNKNOWN
Mohamed Farid Mohamed
CollaboratorUNKNOWN
Hamed Fathy Hamed
CollaboratorUNKNOWN
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

The patients will be randomized into three equal groups. 60 slips of papers will be taken and labeled as group L (LMA), group M (Magnesium sulphate) and group C (Control). These slips will be placed in an envelope and one slip will be raised for each patient.

Intervention model description

We hypothesize that the LMA is more effective than Magnesium sulphate in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. ASA physical status I, II. 2. Ages between 18 and 60 years. 3. Body mass index (BMI) \< 30. 4. Elective surgery

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial blood presure5 minutes from closure of anesthetics until 15 minutes after extubationTotal dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.

Secondary

MeasureTime frameDescription
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 extubationQualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
Level of consciousness5 and 15 minutes after extubationconsciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices
End of surgery and extubationintraoperativeTime interval between end of surgery and extubation in each group

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026