Haemodynamic StabilityPhase 4AnesthesiaNCT04632524
Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection
A Phase 4 study testing MgSO4 in people with Haemodynamic Stability, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemodynamic Stability
- What is being tested?
- MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2020to 30 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients ASA ǀ \&ǁ
- patients of both sex
- Aging from 20-70years
- Pstients with primary or secondary thyrotoxic goiter
Who cannot join
- Major hepatic disease
- renal disease.
- Cardiac dysfunction e.g. (heart Failure).
- Uncontrolled hypertension
- Advanced Ischemic heart diseases.
- Known allergy to Mg So4.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Haemodynamic Stability
- Being tested
- MgSO4
- Keywords
- Thyrotoxic goiter, heamodynamics, magnesium sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure intraoperative
Mean arterial blood pressure measurement in mmHg
Measured: 5 minutes after induction of anesthesia
Oxygen saturation intraoperative
SPO2 Measurement as percentage (%)
Measured: 5 minutes after induction of anesthesia
Heart Rate intraoperative
HR intraoperative beats per minutes
Measured: 5 minutes after induction of anesthesia
Blood pressure postoperative
Mean arterial blood pressure measurement mmHg
Measured: 10minutes after extubation
Heart Rate postoperative
Heart Rate measurement by beats per minutes
Measured: 10 minutes after extubation
Oxygen saturation postoperative
Spo2 measured as percentage %
Measured: 10 minutes after extubation
Secondary outcomes (6)
Sedation score post operative
Sedation score frome 0 point awake and alert to 4 non arousable
Measured: 1 hour post operative
Visual analog scale postoperative(hrs)
A scale for measuring pain from 0 no pain up to 10 worst unbearable pain
Measured: 4 hours post operative
Total opoid consumption intraoperative
Total dose calculated
Measured: 10 minutes after induction of anesthesia
Serum Mg level at the beginning of operation
Blood sample for measuring mg serum level
Measured: 10 minutes after induction of anesthesia
Total opoid consumption postoperative
Total dose calculated postoperative
Measured: 4 hours post operative
Serum Mg level at the end of operation
Blood sample for measuring mg serum level
Measured: 10 minutes befor extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start16 Oct 2020
- Primary completion20 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodynamic StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed Sayed mahmoud, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632524
- Sponsor's protocol ID
- R68
- Acronym
- Anesthesia
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Email inquiry
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04632524
- Acronym / sponsor ID
- Anesthesia / R68
- Conditions
- Haemodynamic Stability
- Keywords
- Thyrotoxic goiter, heamodynamics, magnesium sulphate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MgSO4 | Active comparator | Drug: MgSO4Group (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. |
| Placebo | Placebo comparator | Drug: MgSO4Group (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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients ASA ǀ \&ǁ
- patients of both sex
- Aging from 20-70years
- Pstients with primary or secondary thyrotoxic goiter
Key exclusion criteria (15 listed)
- Major hepatic disease
- renal disease.
- Cardiac dysfunction e.g. (heart Failure).
- Uncontrolled hypertension
- Advanced Ischemic heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MgSO4Group (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. | Drug | MgSO4, Placebo |
Primary outcome
Blood pressure intraoperative
Time frame: 5 minutes after induction of anesthesia
Mean arterial blood pressure measurement in mmHg
Oxygen saturation intraoperative
Time frame: 5 minutes after induction of anesthesia
SPO2 Measurement as percentage (%)
Heart Rate intraoperative
Time frame: 5 minutes after induction of anesthesia
HR intraoperative beats per minutes
Blood pressure postoperative
Time frame: 10minutes after extubation
Mean arterial blood pressure measurement mmHg
Heart Rate postoperative
Time frame: 10 minutes after extubation
Heart Rate measurement by beats per minutes
Oxygen saturation postoperative
Time frame: 10 minutes after extubation
Spo2 measured as percentage %
6 secondary outcomes
Sedation score post operative
Time frame: 1 hour post operative
Visual analog scale postoperative(hrs)
Time frame: 4 hours post operative
Total opoid consumption intraoperative
Time frame: 10 minutes after induction of anesthesia
Serum Mg level at the beginning of operation
Time frame: 10 minutes after induction of anesthesia
Total opoid consumption postoperative
Time frame: 4 hours post operative
Serum Mg level at the end of operation
Time frame: 10 minutes befor extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Results publicationAlessandro 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.
- Individual participant dataSharing planned: No. Email inquiry
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Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MgSO4 in people with Haemodynamic Stability, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure intraoperative (time frame: 5 minutes after induction of anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.