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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406403
• Other study ID #: N-102-2017
• Status: Completed
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Laryngeal 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

Drug:
• Magensium 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

Other:
• Control 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

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (5)

Lead Sponsor	Collaborator
Cairo University	Hamed Fathy Hamed, Mohamed Farid Mohamed, Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial blood presure	Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.	5 minutes from closure of anesthetics until 15 minutes after extubation
Secondary	Intracranial pressure Measurement	Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.	1 and 10 minutes after extubation.
Secondary	Quality of extubation	Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale	Time Onset of cough immediately after extubation
Secondary	Level of consciousness	consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices	5 and 15 minutes after extubation
Secondary	End of surgery and extubation	Time interval between end of surgery and extubation in each group	intraoperative