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

NCT04632524 | Completed Phase 4 DMC

• 1 other identifier: R68
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodynamic Stability

Keywords

Thyrotoxic goiter; heamodynamics; magnesium sulphate

Outcome Measures

Primary Outcomes (6)

• Blood pressure intraoperative

  Mean arterial blood pressure measurement in mmHg

  5 minutes after induction of anesthesia

• Oxygen saturation intraoperative

  SPO2 Measurement as percentage (%)

  5 minutes after induction of anesthesia

• Heart Rate intraoperative

  HR intraoperative beats per minutes

  5 minutes after induction of anesthesia

• Blood pressure postoperative

  Mean arterial blood pressure measurement mmHg

  10minutes after extubation

• Heart Rate postoperative

  Heart Rate measurement by beats per minutes

  10 minutes after extubation

• Oxygen saturation postoperative

  Spo2 measured as percentage %

  10 minutes after extubation

Secondary Outcomes (6)

• Sedation score post operative

  1 hour post operative

• Visual analog scale postoperative(hrs)

  4 hours post operative

• Total opoid consumption intraoperative

  10 minutes after induction of anesthesia

• Serum Mg level at the beginning of operation

  10 minutes after induction of anesthesia

• Total opoid consumption postoperative

  4 hours post operative

Study Arms (2)

MgSO4

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

MgSO4; Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Atef

Al Fayyum, 63512, Egypt

Location

Related Publications (1)

• 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.

  RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: November 17, 2020
• Study Start: October 16, 2020
• Primary Completion: January 20, 2022
• Study Completion: January 30, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)