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

Sponsor

Fayoum University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04632524

Collaborator

(none)

Enrollment

Location

Arms

27.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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.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 :

Oct 16, 2019

Anticipated Primary Completion Date :

Dec 20, 2021

Anticipated Study Completion Date :

Jan 30, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Blood pressure intraoperative [5 minutes after induction of anesthesia]
Mean arterial blood pressure measurement in mmHg
Oxygen saturation intraoperative [5 minutes after induction of anesthesia]
SPO2 Measurement as percentage (%)
Heart Rate intraoperative [5 minutes after induction of anesthesia]
HR intraoperative beats per minutes
Blood pressure postoperative [10minutes after extubation]
Mean arterial blood pressure measurement mmHg
Heart Rate postoperative [10 minutes after extubation]
Heart Rate measurement by beats per minutes
Oxygen saturation postoperative [10 minutes after extubation]
Spo2 measured as percentage %

Secondary Outcome Measures

Sedation score post operative [1 hour post operative]
Sedation score frome 0 point awake and alert to 4 non arousable
Visual analog scale postoperative(hrs) [4 hours post operative]
A scale for measuring pain from 0 no pain up to 10 worst unbearable pain
Total opoid consumption intraoperative [10 minutes after induction of anesthesia]
Total dose calculated
Serum Mg level at the beginning of operation [10 minutes after induction of anesthesia]
Blood sample for measuring mg serum level
Total opoid consumption postoperative [4 hours post operative]
Total dose calculated postoperative
Serum Mg level at the end of operation [10 minutes befor extubation]
Blood sample for measuring mg serum level

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atef	Fayoum		Egypt	63512

Sponsors and Collaborators

Fayoum University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Atef Mohamed Sayed mahmoud, Principal investigator, Fayoum University Hospital

ClinicalTrials.gov Identifier:

NCT04632524

Other Study ID Numbers:

First Posted:

Nov 17, 2020

Last Update Posted:

Aug 19, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Atef Mohamed Sayed mahmoud, Principal investigator, Fayoum University Hospital

Thyrotoxic goiter

heamodynamics

magnesium sulphate

Additional relevant MeSH terms:

Goiter

Study Results

No Results Posted as of Aug 19, 2021