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

Haemodynamic Stability Clinical Trial

— Anesthesia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632524
• Other study ID #: R68
• Status: Completed
• Phase: Phase 4
• Start date: October 16, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: September 2022
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. patients ASA | &?

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.

Related Conditions & MeSH terms

• Goiter
• Haemodynamic Stability

Intervention

Drug:
• MgSO4
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.

Locations

Country	Name	City	State
Egypt	Atef	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Ma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure intraoperative	Mean arterial blood pressure measurement in mmHg	5 minutes after induction of anesthesia
Primary	Oxygen saturation intraoperative	SPO2 Measurement as percentage (%)	5 minutes after induction of anesthesia
Primary	Heart Rate intraoperative	HR intraoperative beats per minutes	5 minutes after induction of anesthesia
Primary	Blood pressure postoperative	Mean arterial blood pressure measurement mmHg	10minutes after extubation
Primary	Heart Rate postoperative	Heart Rate measurement by beats per minutes	10 minutes after extubation
Primary	Oxygen saturation postoperative	Spo2 measured as percentage %	10 minutes after extubation
Secondary	Sedation score post operative	Sedation score frome 0 point awake and alert to 4 non arousable	1 hour post operative
Secondary	Visual analog scale postoperative(hrs)	A scale for measuring pain from 0 no pain up to 10 worst unbearable pain	4 hours post operative
Secondary	Total opoid consumption intraoperative	Total dose calculated	10 minutes after induction of anesthesia
Secondary	Serum Mg level at the beginning of operation	Blood sample for measuring mg serum level	10 minutes after induction of anesthesia
Secondary	Total opoid consumption postoperative	Total dose calculated postoperative	4 hours post operative
Secondary	Serum Mg level at the end of operation	Blood sample for measuring mg serum level	10 minutes befor extubation