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

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

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.

Study Overview

• Status: Completed
• Conditions: Haemodynamic Stability
• Intervention / Treatment: Drug: MgSO4

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 63512
    • Atef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
PLACEBO_COMPARATOR: Placebo; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fayoum University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2020
• Primary Completion (ACTUAL): January 20, 2022
• Study Completion (ACTUAL): January 30, 2022

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: magnesium sulphate; Thyrotoxic goiter; heamodynamics
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Goiter
• Other Study ID Numbers: R68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Email inquiry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No