Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection

Study Overview
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Brief Summary
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Anesthesia for toxic goiter removal is a challenging because of of hemodynamic instability especially during induction, intubation, manipulations of the gland, after removal of the gland and during emergence. So, hemodynamic stability is required all through the operation and even in the first 12 hours of the postoperative period to protect against complications e.g., hypertension, tachycardia, myocardial ischemia, bleeding and thyrotoxic crisis.Mg sulphate used in blunting pressor response during laryngoscopy and intubation. Also it was used in controlled hypotension technique. Also it was reported in decreasing postoperative nausea, vomiting, shivering and postoperative complications compared to controlled group.

Detailed Description
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Patients and Methods: After obtaining the approval of the Ethical Committee number (R68) of Al Fayoum University Hospitals and written informed consent from the patients, sixty (60) patients ASA ǀ &ǁ patients of both sex aging 20-70 years (with primary or secondary thyrotoxic goiter and will be presented for thyroidectomy) will be allocated into one of two groups: Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.

Official Title
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Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial

Conditions
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Haemodynamic Stability

Intervention / Treatment
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* Drug: MgSO4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ASA ǀ &ǁ patients of both sex Aging from 20-70years Pstients with primary or secondary thyrotoxic goiter Exclusion Criteria: Major hepatic disease renal disease. Cardiac dysfunction e.g. (heart Failure). Uncontrolled hypertension Advanced Ischemic heart diseases. Known allergy to Mg So4. Morbid obesity & pregnancy. History of neuromuscular diseases. cerebrovascular diseases. Diabetic neuropathy. patients receiving magnesium. supplementations. Mental retardation Patients on antiepileptic treatment patients antipsychotics. Hug goiter with retrosternal extension.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sixty (60) patients ASA ǀ &ǁ patients of both sex aging 16-78 years (with primary or secondary thyrotoxic goiter and will be presented for thyroidectomy) will be allocated into one of two groups: Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MgSO4<br>Group (Mg So4) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. | Drug: MgSO4<br>* Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.<br>|
| Placebo Comparator: Placebo<br>Group (P) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse | Drug: MgSO4<br>* Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure intraoperative | Mean arterial blood pressure measurement in mmHg | 5 minutes after induction of anesthesia | 
| Oxygen saturation intraoperative | SPO2 Measurement as percentage (%) | 5 minutes after induction of anesthesia | 
| Heart Rate intraoperative | HR intraoperative beats per minutes | 5 minutes after induction of anesthesia | 
| Blood pressure postoperative | Mean arterial blood pressure measurement mmHg | 10minutes after extubation | 
| Heart Rate postoperative | Heart Rate measurement by beats per minutes | 10 minutes after extubation | 
| Oxygen saturation postoperative | Spo2 measured as percentage % | 10 minutes after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation score post operative | Sedation score frome 0 point awake and alert to 4 non arousable | 1 hour post operative | 
| Visual analog scale postoperative(hrs) | A scale for measuring pain from 0 no pain up to 10 worst unbearable pain | 4 hours post operative | 
| Total opoid consumption intraoperative | Total dose calculated | 10 minutes after induction of anesthesia | 
| Serum Mg level at the beginning of operation | Blood sample for measuring mg serum level | 10 minutes after induction of anesthesia | 
| Total opoid consumption postoperative | Total dose calculated postoperative | 4 hours post operative | 
| Serum Mg level at the end of operation | Blood sample for measuring mg serum level | 10 minutes befor extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyrotoxic goiter, heamodynamics, magnesium sulphate