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Completed

NCT Number: NCT03406403

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

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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)

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intracranial pressure Measurement

    Time frame: 1 and 10 minutes after extubation.

    Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.

  2. Quality of extubation

    Time frame: Time Onset of cough immediately after extubation

    Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale

  3. Level of consciousness

    Time frame: 5 and 15 minutes after extubation

    consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices

  4. End of surgery and extubation

    Time frame: intraoperative

    Time interval between end of surgery and extubation in each group

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Hamed Fathy Hamed
  • Mohamed Farid Mohamed
  • Mohamed, Ahmed A., M.D.
  • Tarek Ahmed Radwan

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.