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

Phase 4

Completed

• Conditions: Haemodynamic Stability
• Interventions: Drug: MgSO4

• Registration Number: NCT04632524
• Lead Sponsor: Fayoum University Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-30
• Study Start: 2020-10-16
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-17
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4	MgSO4	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.
Placebo	MgSO4	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Atef; 🇪🇬 Fayoum, Egypt