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

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ClinicalTrials.gov Identifier: NCT04632524
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Atef Mohamed Sayed mahmoud, Fayoum University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Haemodynamic Stability Drug: MgSO4 Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: The patients were randomly allocated by a computer-generated table into one of two study groups. The randomization sequence was concealed in opaque sealed envelopes. The envelopes were opened by the study investigators just after recruitments and admission to the operation room.
Primary Purpose: Other
Official Title: Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : January 30, 2022

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure intraoperative [ Time Frame: 5 minutes after induction of anesthesia ]
    Mean arterial blood pressure measurement in mmHg

  2. Oxygen saturation intraoperative [ Time Frame: 5 minutes after induction of anesthesia ]
    SPO2 Measurement as percentage (%)

  3. Heart Rate intraoperative [ Time Frame: 5 minutes after induction of anesthesia ]
    HR intraoperative beats per minutes

  4. Blood pressure postoperative [ Time Frame: 10minutes after extubation ]
    Mean arterial blood pressure measurement mmHg

  5. Heart Rate postoperative [ Time Frame: 10 minutes after extubation ]
    Heart Rate measurement by beats per minutes

  6. Oxygen saturation postoperative [ Time Frame: 10 minutes after extubation ]
    Spo2 measured as percentage %


Secondary Outcome Measures :
  1. Sedation score post operative [ Time Frame: 1 hour post operative ]
    Sedation score frome 0 point awake and alert to 4 non arousable

  2. Visual analog scale postoperative(hrs) [ Time Frame: 4 hours post operative ]
    A scale for measuring pain from 0 no pain up to 10 worst unbearable pain

  3. Total opoid consumption intraoperative [ Time Frame: 10 minutes after induction of anesthesia ]
    Total dose calculated

  4. Serum Mg level at the beginning of operation [ Time Frame: 10 minutes after induction of anesthesia ]
    Blood sample for measuring mg serum level

  5. Total opoid consumption postoperative [ Time Frame: 4 hours post operative ]
    Total dose calculated postoperative

  6. Serum Mg level at the end of operation [ Time Frame: 10 minutes befor extubation ]
    Blood sample for measuring mg serum level


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632524


Locations
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Egypt
Atef Recruiting
Fayoum, Egypt, 63512
Contact: Atef Mohamed Mahmoud, Lecture    01003973883    dr.atef.khalil@gmail.com   
Principal Investigator: Atef Mohamed Mahmoud, Lecturer         
Sponsors and Collaborators
Fayoum University Hospital
More Information
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Publications of Results:
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.

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Responsible Party: Atef Mohamed Sayed mahmoud, Principal investigator, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT04632524    
Other Study ID Numbers: R68
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Email inquiry

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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
Keywords provided by Atef Mohamed Sayed mahmoud, Fayoum University Hospital:
Thyrotoxic goiter
heamodynamics
magnesium sulphate
Additional relevant MeSH terms:
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Goiter
Thyroid Diseases
Endocrine System Diseases