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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.

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laryngeal mask airway
Magensium sulphate
Control group (closure of anesthetics)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ahmed Abdalla Mohamed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Laryngeal mask airway group

Magensium sulphate group

Control group (closure of anesthetics)

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Quality of extubation
Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
Level of consciousness
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 extubation
Time interval between end of surgery and extubation in each group

Full Information

First Posted
December 26, 2017
Last Updated
June 3, 2018
Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Farid Mohamed, Hamed Fathy Hamed
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1. Study Identification

Unique Protocol Identification Number
NCT03406403
Brief Title
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Official Title
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Farid Mohamed, Hamed Fathy Hamed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare Provider
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laryngeal mask airway group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Magensium sulphate group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group (closure of anesthetics)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laryngeal mask airway
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Magensium sulphate
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group (closure of anesthetics)
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean arterial blood presure
Description
Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.
Time Frame
5 minutes from closure of anesthetics until 15 minutes after extubation
Secondary Outcome Measure Information:
Title
Intracranial pressure Measurement
Description
Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.
Time Frame
1 and 10 minutes after extubation.
Title
Quality of extubation
Description
Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
Time Frame
Time Onset of cough immediately after extubation
Title
Level of consciousness
Description
consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices
Time Frame
5 and 15 minutes after extubation
Title
End of surgery and extubation
Description
Time interval between end of surgery and extubation in each group
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamed Fathy, M.S
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Via scholar Gate

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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.

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