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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04632524
Acronym
Anesthesia
Enrollment
60
Registered
2020-11-17
Start date
2020-10-16
Completion date
2022-01-30
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodynamic Stability

Keywords

Thyrotoxic goiter, heamodynamics, magnesium sulphate

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.

Interventions

DRUGMgSO4

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.

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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.

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxygen saturation postoperative10 minutes after extubationSpo2 measured as percentage %
Blood pressure intraoperative5 minutes after induction of anesthesiaMean arterial blood pressure measurement in mmHg
Oxygen saturation intraoperative5 minutes after induction of anesthesiaSPO2 Measurement as percentage (%)
Heart Rate intraoperative5 minutes after induction of anesthesiaHR intraoperative beats per minutes
Blood pressure postoperative10minutes after extubationMean arterial blood pressure measurement mmHg
Heart Rate postoperative10 minutes after extubationHeart Rate measurement by beats per minutes

Secondary

MeasureTime frameDescription
Sedation score post operative1 hour post operativeSedation score frome 0 point awake and alert to 4 non arousable
Visual analog scale postoperative(hrs)4 hours post operativeA scale for measuring pain from 0 no pain up to 10 worst unbearable pain
Total opoid consumption intraoperative10 minutes after induction of anesthesiaTotal dose calculated
Serum Mg level at the beginning of operation10 minutes after induction of anesthesiaBlood sample for measuring mg serum level
Total opoid consumption postoperative4 hours post operativeTotal dose calculated postoperative
Serum Mg level at the end of operation10 minutes befor extubationBlood sample for measuring mg serum level

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026