Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection (Anesthesia)
Primary Purpose
Haemodynamic Stability
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
MgSO4
Sponsored by
About this trial
This is an interventional other trial for Haemodynamic Stability focused on measuring Thyrotoxic goiter, heamodynamics, magnesium sulphate
Eligibility Criteria
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.
Sites / Locations
- Atef
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MgSO4
Placebo
Arm Description
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 (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
Outcomes
Primary Outcome Measures
Blood pressure intraoperative
Mean arterial blood pressure measurement in mmHg
Oxygen saturation intraoperative
SPO2 Measurement as percentage (%)
Heart Rate intraoperative
HR intraoperative beats per minutes
Blood pressure postoperative
Mean arterial blood pressure measurement mmHg
Heart Rate postoperative
Heart Rate measurement by beats per minutes
Oxygen saturation postoperative
Spo2 measured as percentage %
Secondary Outcome Measures
Sedation score post operative
Sedation score frome 0 point awake and alert to 4 non arousable
Visual analog scale postoperative(hrs)
A scale for measuring pain from 0 no pain up to 10 worst unbearable pain
Total opoid consumption intraoperative
Total dose calculated
Serum Mg level at the beginning of operation
Blood sample for measuring mg serum level
Total opoid consumption postoperative
Total dose calculated postoperative
Serum Mg level at the end of operation
Blood sample for measuring mg serum level
Full Information
NCT ID
NCT04632524
First Posted
August 30, 2020
Last Updated
September 6, 2022
Sponsor
Fayoum University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04632524
Brief Title
Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection
Acronym
Anesthesia
Official Title
Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemodynamic Stability
Keywords
Thyrotoxic goiter, heamodynamics, magnesium sulphate
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MgSO4
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
MgSO4
Intervention Description
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 Outcome Measure Information:
Title
Blood pressure intraoperative
Description
Mean arterial blood pressure measurement in mmHg
Time Frame
5 minutes after induction of anesthesia
Title
Oxygen saturation intraoperative
Description
SPO2 Measurement as percentage (%)
Time Frame
5 minutes after induction of anesthesia
Title
Heart Rate intraoperative
Description
HR intraoperative beats per minutes
Time Frame
5 minutes after induction of anesthesia
Title
Blood pressure postoperative
Description
Mean arterial blood pressure measurement mmHg
Time Frame
10minutes after extubation
Title
Heart Rate postoperative
Description
Heart Rate measurement by beats per minutes
Time Frame
10 minutes after extubation
Title
Oxygen saturation postoperative
Description
Spo2 measured as percentage %
Time Frame
10 minutes after extubation
Secondary Outcome Measure Information:
Title
Sedation score post operative
Description
Sedation score frome 0 point awake and alert to 4 non arousable
Time Frame
1 hour post operative
Title
Visual analog scale postoperative(hrs)
Description
A scale for measuring pain from 0 no pain up to 10 worst unbearable pain
Time Frame
4 hours post operative
Title
Total opoid consumption intraoperative
Description
Total dose calculated
Time Frame
10 minutes after induction of anesthesia
Title
Serum Mg level at the beginning of operation
Description
Blood sample for measuring mg serum level
Time Frame
10 minutes after induction of anesthesia
Title
Total opoid consumption postoperative
Description
Total dose calculated postoperative
Time Frame
4 hours post operative
Title
Serum Mg level at the end of operation
Description
Blood sample for measuring mg serum level
Time Frame
10 minutes befor extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Atef
City
Fayoum
ZIP/Postal Code
63512
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Email inquiry
Citations:
Citation
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.
Results Reference
result
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Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection
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