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

NCT03406403 | Completed DMC FDA Device

• 1 other identifier: N-102-2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intracranial pressure Measurement

  1 and 10 minutes after extubation.

• Quality of extubation

  Time Onset of cough immediately after extubation

• Level of consciousness

  5 and 15 minutes after extubation

• End of surgery and extubation

  intraoperative

Study Arms (3)

Laryngeal mask airway group

ACTIVE COMPARATOR

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.

Device: Laryngeal mask airway; Drug: Magensium sulphate; Other: Control group (closure of anesthetics)

Magensium sulphate group

ACTIVE COMPARATOR

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

Device: Laryngeal mask airway; Drug: Magensium sulphate; Other: Control group (closure of anesthetics)

Control group (closure of anesthetics)

ACTIVE COMPARATOR

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.

Device: Laryngeal mask airway; Drug: Magensium sulphate; Other: Control group (closure of anesthetics)

Interventions

Laryngeal mask airway DEVICE

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

Control group (closure of anesthetics); Laryngeal mask airway group; Magensium sulphate group

Magensium sulphate DRUG

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

Control group (closure of anesthetics); Laryngeal mask airway group; Magensium sulphate group

Control group (closure of anesthetics) OTHER

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

Control group (closure of anesthetics); Laryngeal mask airway group; Magensium sulphate group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Tarek Ahmed Radwan: collaborator
• Mohamed Farid Mohamed: collaborator
• Hamed Fathy Hamed: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Laryngeal Masks; Control Groups

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods

Study Officials

• Hamed Fathy, M.S

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

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

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 23, 2018
• Study Start: January 19, 2018
• Primary Completion: May 31, 2018
• Study Completion: June 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

EG (1)