Clinical trial NCT04632524: Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection
Official title: Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Haemodynamic Stability
Keywords: Thyrotoxic goiter
heamodynamics
magnesium sulphate
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. patients ASA ǀ \&ǁ
2. patients of both sex
3. Aging from 20-70years
4. Pstients with primary or secondary thyrotoxic goiter

Exclusion Criteria:

1. Major hepatic disease
2. renal disease.
3. Cardiac dysfunction e.g. (heart Failure).
4. Uncontrolled hypertension
5. Advanced Ischemic heart diseases.
6. Known allergy to Mg So4.
7. Morbid obesity \& pregnancy.
8. History of neuromuscular diseases.
9. cerebrovascular diseases.
10. Diabetic neuropathy.
11. patients receiving magnesium. supplementations.
12. Mental retardation
13. Patients on antiepileptic treatment
14. patients antipsychotics.
15. Hug goiter with retrosternal extension.

Primary outcomes:
measure: Blood pressure intraoperative
timeFrame: 5 minutes after induction of anesthesia
measure: Oxygen saturation intraoperative
timeFrame: 5 minutes after induction of anesthesia
measure: Heart Rate intraoperative
timeFrame: 5 minutes after induction of anesthesia
measure: Blood pressure postoperative
timeFrame: 10minutes after extubation
measure: Heart Rate postoperative
timeFrame: 10 minutes after extubation
measure: Oxygen saturation postoperative
timeFrame: 10 minutes after extubation
Secondary outcomes:
measure: Sedation score post operative
timeFrame: 1 hour post operative
measure: Visual analog scale postoperative(hrs)
timeFrame: 4 hours post operative
measure: Total opoid consumption intraoperative
timeFrame: 10 minutes after induction of anesthesia
measure: Serum Mg level at the beginning of operation
timeFrame: 10 minutes after induction of anesthesia
measure: Total opoid consumption postoperative
timeFrame: 4 hours post operative
measure: Serum Mg level at the end of operation
timeFrame: 10 minutes befor extubation
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Atef
Study officials:
References:
citation: Alessandro Bacuzzi, Gianlorenzo Dionigi, Andrea Del Bosco, Giovanni Cantone, Tommaso Sansone, Erika Di Losa, Salvatore Cuffari. Anaesthesia for thyroid surgery: Perioperative management. International Journal of Surgery (2008);6: S82-S85. Sang-Hawn Do. Magnesium: a versatile drug for anesthesiologists. Korea J Anesthesiology 2013; 65 (1):4-8. Tramer MR, Shneider j, Marti RA, Rifat K. Role of magnesium sulfate in postoperative analgesia. Anesthesiology 1996; 84:340-7. Ryu JH, Sohn IS, Do SH. Controlled hypotension for middle ear surgery: a comparison between remifentanil and magnesium sulphate. Br J Anaesth 2009; 103: 490-5.