LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours PatientsNCT03406403
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
A study testing Laryngeal mask airway and Magensium sulphate in people with LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients
- What is being tested?
- Laryngeal mask airway and Magensium sulphate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I, II.
- Ages between 18 and 60 years.
- Body mass index (BMI) < 30.
- Elective surgery
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients
- Being tested
- Laryngeal mask airway, Magensium sulphate, Control group (closure of anesthetics)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airwayDevice
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
Magensium sulphateDrug
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)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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Device: Laryngeal mask airway; Drug: Magensium sulphate; Other: Control group (closure of anesthetics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood presure
Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.
Measured: 5 minutes from closure of anesthetics until 15 minutes after extubation
Secondary outcomes (4)
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.
Measured: 1 and 10 minutes after extubation.
Quality of extubation
Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
Measured: Time Onset of cough immediately after extubation
Level of consciousness
consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices
Measured: 5 and 15 minutes after extubation
End of surgery and extubation
Time interval between end of surgery and extubation in each group
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start19 Jan 2018
- Primary completion31 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Farid Mohamed, Hamed Fathy Hamed
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Hamed Fathy, M.S, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406403
- Sponsor's protocol ID
- N-102-2017
- Status last verified
- Jun 2018
- First submitted
- 26 Dec 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Via scholar Gate
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
- ClinicalTrials.gov ID
- NCT03406403
- Acronym / sponsor ID
- N-102-2017
- Conditions
- LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Farid Mohamed, Hamed Fathy Hamed
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask airway group | Active comparator | Device: Laryngeal mask airway, Drug: Magensium sulphate, Other: Control 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 group | Active comparator | Device: Laryngeal mask airway, Drug: Magensium sulphate, Other: Control 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) | Active comparator | Device: Laryngeal mask airway, Drug: Magensium sulphate, Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I, II.
- Ages between 18 and 60 years.
- Body mass index (BMI) < 30.
- Elective surgery
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal mask airwayAfter 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 | Device | Control group (closure of anesthetics), Laryngeal mask airway group, Magensium sulphate group |
| Magensium sulphateAfter 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 | Control group (closure of anesthetics), Laryngeal mask airway group, Magensium sulphate group |
| 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 | Other | Control group (closure of anesthetics), Laryngeal mask airway group, Magensium sulphate group |
Primary outcome
Mean arterial blood presure
Time frame: 5 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.
4 secondary outcomes
Intracranial pressure Measurement
Time frame: 1 and 10 minutes after extubation.
Quality of extubation
Time frame: Time Onset of cough immediately after extubation
Level of consciousness
Time frame: 5 and 15 minutes after extubation
End of surgery and extubation
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: Undecided. Via scholar Gate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamed Fathy, M.S principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask airway and Magensium sulphate in people with LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood presure (time frame: 5 minutes from closure of anesthetics until 15 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.