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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2022-01-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Haemodynamic Stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

MgSO4

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

MgSO4

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes