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NCT Number: NCT04632524

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

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.

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Key information

Conditions

Haemodynamic Stability

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atef

Al Fayyum, 63512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients ASA ǀ &ǁ
  • patients of both sex
  • Aging from 20-70years
  • Pstients with primary or secondary thyrotoxic goiter

Exclusion criteria

  • Major hepatic disease
  • renal disease.
  • Cardiac dysfunction e.g. (heart Failure).
  • Uncontrolled hypertension
  • Advanced Ischemic heart diseases.
  • Known allergy to Mg So4.
  • Morbid obesity & pregnancy.
  • History of neuromuscular diseases.
  • cerebrovascular diseases.
  • Diabetic neuropathy.
  • patients receiving magnesium. supplementations.
  • Mental retardation
  • Patients on antiepileptic treatment
  • patients antipsychotics.
  • Hug goiter with retrosternal extension.

Treatment and study plan

MgSO4

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Acronym: Anesthesia

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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