Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204562765688 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic and hemodynamic effects of intravenous magnesium sulfate infusion versus lidocaine infusion in patients undergoing thyroid surgery for toxic goiter resection
Official scientific title Analgesic and hemodynamic effects of intravenous magnesium sulfate infusion versus lidocaine infusion in patients undergoing thyroid surgery for toxic goiter resection: a randomized controlled study
Brief summary describing the background and objectives of the trial Anesthesia for toxic goiter removal is challenging because surgical manipulations of the gland and inadequate pain control can induce complex stress responses with neurohumoral, metabolic, and immunological changes that may be manifested as hemodynamic instability in the form of an increase in heart rate and blood pressure, hyperglycemia, and release of different cytokines. So, hemodynamic stability is required all through the operation and even in the first 12 hours of the postoperative period to protect against complications. Different techniques or medications like local anesthetics infiltration, opioid, and anesthetic addictive drugs have been used to improve the quality of postoperative pain, achievement of more balanced anesthetic doses, hemodynamic stabilization, and improvement of surgical conditions for better quality of recovery after anesthesia. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic, and endocrine reflexes provoked by noxious stimuli. Also, Magnesium was used in blunting pressor response during laryngoscopy and intubation and to produce a controlled hypotension technique. Lidocaine is a local anesthetic drug that produces analgesic and antihyperalgesic effects by modifying the response of neurons in the dorsal horn to noxious stimuli, and it has an anti-inflammatory effect by inhibiting migration and metabolic activation of leukocytes. Lidocaine can provide these effects through various mechanisms such as sodium channel blocking and inhibition of both G protein and NMDA receptors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 18/04/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date 10/03/2023
Anticipated target sample size (number of participants) 57
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lidocaine Group once patients will receive lidocaine pre-induction as an intravenous bolus of 3mg/kg over 10 minutes and a maintenance dose intraoperative 3/mg/kg/h intravenous and discontinued just before the end of the surgery 19
Experimental Group Mg So4 Group once patients will receive Mg So4 pre-induction as an intravenous bolus of 40mg/kg over 10 minutes and a maintenance dose intraoperative 20/mg/kg/h intravenous and discontinued just before the end of the surgery 19
Control Group Control Group once patients will receive saline in equal volume. 19 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-patients of both sex - Aging from 20-60 years - Patients with primary or secondary thyrotoxic goiter. - American Society of Anesthesiologists (ASA) classes I or II  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  Patient's on antipsychotics.  Huge goiter with retrosternal extension Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/03/2022 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board- IRB- office building A- ground floor- faculty of medicine-Mansoura University Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative pain measured by VAS score VAS score will be assessed immediately after the procedures, 1h, 3h, 6h, 12h, and 24h postoperatively
Primary Outcome Hemodynamic parameters (mean arterial blood pressure and heart rate) intra operative at different 5 times interval and every fifteen minutes
Secondary Outcome Time of first analgesic request. immediately post operative
Secondary Outcome Total opioid consumption postoperative within 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Elgomhouria St., Mansoura City, Egypt Mansoura City 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Gad Elhouty Elgomhouria St., Mansoura City, Egypt Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhouria St., Mansoura City, Egypt Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elhouty mohamedsarah862@gmail.com 01093019320 Elgomhouria Street
City Postal code Country Position/Affiliation
Mansoura City 35516 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Khaled Elbahrawy dr_mohamedgad2000@yahoo.com 01121011768 Elgomhouria Street
City Postal code Country Position/Affiliation
Mansoura City 35516 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed Sakr ahmadsakr1987@gmail.com 01004421980 Elgomhouria Street
City Postal code Country Position/Affiliation
Mansoura City 35516 Egypt Lecturer of general surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information