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CompletedNCT03406403Updated Jun 6, 2018

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

An interventional study of Laryngeal mask airway and Magensium sulphate in LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Laryngeal mask airway group

    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)

  • Active comparator
    Magensium sulphate group

    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)

  • Active comparator
    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.

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

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

05

What researchers measure

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.

    Time frame: 5 minutes from closure of anesthetics until 15 minutes after extubation

Secondary outcomes

  1. 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.

    Time frame: 1 and 10 minutes after extubation.

  2. Quality of extubation

    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

  3. Level of consciousness

    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

  4. End of surgery and extubation

    Time interval between end of surgery and extubation in each group

    Time frame: intraoperative

06

Study locations

1 site
  • Ahmed Abdalla Mohamed
    Cairo, 11451, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided — Via scholar Gate

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406403
Lead sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Tarek Ahmed Radwan, Mohamed Farid Mohamed, Hamed Fathy Hamed
Responsible party
Ahmed Abdalla (Assistant Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University) — Principal investigator
First posted
Jan 23, 2018
Start date
Jan 19, 2018
Primary completion
May 31, 2018
Completion
Jun 1, 2018
Last update
Jun 6, 2018

Study contacts

Hamed Fathy, M.S
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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