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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609730724137 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title How much can magnesium reduce the need for muscle relaxant drugs during lumbar fusion surgery?
Official scientific title Effect of magnesium on curare consumption during posterior lumbar interbody fusion in neurosurgery: Randomized controlled Trial.
Brief summary describing the background and objectives of the trial Magnesium sulfate is used in anesthesiology and critical care for its analgesic, anxiolytic, antiarrhythmic, vasodilatory, and bronchodilatory properties. It also potentiates the effects of volatile anesthetics and non-depolarizing neuromuscular blocking agents. During lumbar fusion neurosurgery, optimal neuromuscular blockade is essential to ensure adequate surgical conditions. However, excessive use of neuromuscular blocking agents can prolong recovery time and increase the risk of residual neuromuscular blockade and postoperative respiratory complications. The primary objective of this randomized controlled trial is to compare the effect of continuous magnesium infusion on cisatracurium consumption, compared with no magnesium administration, using neuromuscular monitoring in patients undergoing thoracolumbar spinal fusion surgery. Secondary objectives are to compare the intraoperative sufentanil consumption between the two groups and to assess potential adverse effects associated with magnesium administration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2025
Actual trial start date 15/05/2026
Anticipated date of last follow up 31/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
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 Allocation Sequence/Code was not concealed Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnesium Magnesium sulfate (15% solution) will be administered as a continuous maintenance infusion at a rate of 1.5 g/h, with a maximum total dose of 6 g. The infusion will be delivered at a rate of 10 mL/h. This corresponds to an approximate dose of 15–25 mg/kg/h in the study population, based on inclusion criteria with actual body weight ranging from 60 to 95 kg. Infusion will continue for the duration of surgery, up to a maximum of 4 hours. Magnesium sulfate will be administered by electric syringe pump (continuous infusion) as a maintenance dose without a loading dose. Infusion will begin 10 minutes after surgical positioning and after confirmation of hemodynamic stability, through a dedicated 20 gauge peripheral intravenous line in the upper extremity. Infusion will be stopped at the beginning of surgical wound closure, or when a total dose of 6 g is reached, or in the case of protocol-defined discontinuation criteria. 21
Control Group Control For the control group (CG), no placebo or additional treatment will be administered. No placebo or additional treatment will be administered during the surgery. The control group will receive standard care with no additional intervention. 21 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients aged 18 years or older American Society of Anesthesiologists (ASA) physical status I–III Body weight between 60 and 95 kg (actual body weight) Scheduled for thoracolumbar spinal fixation surgery Surgery performed in the knee-chest position Provision of written informed consent before surgery Known myasthenia gravis Renal impairment (creatinine clearance < 50 mL/min) Known hypersensitivity to magnesium Osteoporosis treated with bisphosphonates Non-paced atrioventricular block Baseline heart rate < 55 beats per minute History of torsades de pointes Current treatment with antiarrhythmic or digitalis medications Chronic diarrhea Excessive alcohol consumption Requirement for rapid sequence induction Occurrence of perioperative bronchospasm Severe hypotension requiring norepinephrine Symptomatic hypocalcemia requiring calcium administration Surgery duration < 90 minutes 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 27/03/2025 Comite de la facult de Medecine Ibn El Jazzar de Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse Sousse 4002 Tunisia
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 05/03/2025 Comite d ethique de CHU Sahloul Sousse
Ethics Committee Address
Street address City Postal code Country
route de ceinture, Hammem Sousse, Sahloul Sousse 4011 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cisatracurium consumption expressed in µg/kg/min. For the duration of neuromuscular blockade, that was defined as the time from induction of anesthesia to the beginning of surgical wound closur
Secondary Outcome Sufentanil consumption expressed in ng/kg/min. For the duration of neuromuscular blockade, that was defined as the time from induction of anesthesia to the beginning of surgical wound closure
Secondary Outcome Adverse events related to magnesium administration (bradycardia, hypotension, respiratory depression, diarrhea, and postoperative nausea and vomiting) perioperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul University Hospital Center Route de la Ceinture Sahloul Hammam Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Hospital Route de ceinture, Hammam Sousse, Sahloul Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Departement of anesthesiology Sahloul hospital Route de centure, Hammam Sousse, Sahloul Sousse 4011 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Departement of anesthesiology Sahloul hospital Team Route de ceinture, Hammam Sousse, Sahloul Sousse 4011 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Souha Guellim souha.guellim@famso.u-sousse.tn 21697848870 Route de ceinture, Hammam Sousse, sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
Role Name Email Phone Street address
Public Enquiries Soussi Mohamed mohamed.soussidoc@gmail.com 21699210080 Route de ceinture, Hammam Sousse, sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
Role Name Email Phone Street address
Scientific Enquiries Souha Guellim souha.guellim@famso.u-sousse.tn 21697848870 Route de ceinture, Hammam Sousse, sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be publicly available. Anonymized data may be shared with qualified researchers upon reasonable request and following approval by the relevant ethics committee. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available after publication of the main study results and upon reasonable request Access will be considered upon reasonable request from qualified researchers with a scientifically valid proposal. Data access will require approval by the study investigators and the relevant ethics committee, and will be limited to anonymized data.
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/09/2026 PACTR Admin Experimental Group, Magnesium group, Magnesium sulfate (15% solution) will be administered as a continuous maintenance infusion at a rate of 1.5 g/h, with a maximum total dose of 6 g. The infusion will be delivered at a rate of 10 mL/h. This corresponds to an approximate dose of 15–25 mg/kg/h in the study population, based on inclusion criteria with actual body weight ranging from 60 to 95 kg., Infusion will continue for the duration of surgery, up to a maximum of 4 hours., Magnesium sulfate will be administered by electric syringe pump (continuous infusion) as a maintenance dose without a loading dose. Infusion will begin 10 minutes after surgical positioning and after confirmation of hemodynamic stability, through a dedicated 20 gauge peripheral intravenous line in the upper extremity. Infusion will be stopped at the beginning of surgical wound closure, or when a total dose of 6 g is reached, or in the case of protocol-defined discontinuation criteria., 21, Experimental Group, Magnesium , Magnesium sulfate (15% solution) will be administered as a continuous maintenance infusion at a rate of 1.5 g/h, with a maximum total dose of 6 g. The infusion will be delivered at a rate of 10 mL/h. This corresponds to an approximate dose of 15–25 mg/kg/h in the study population, based on inclusion criteria with actual body weight ranging from 60 to 95 kg., Infusion will continue for the duration of surgery, up to a maximum of 4 hours., Magnesium sulfate will be administered by electric syringe pump (continuous infusion) as a maintenance dose without a loading dose. Infusion will begin 10 minutes after surgical positioning and after confirmation of hemodynamic stability, through a dedicated 20 gauge peripheral intravenous line in the upper extremity. Infusion will be stopped at the beginning of surgical wound closure, or when a total dose of 6 g is reached, or in the case of protocol-defined discontinuation criteria., 21,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/09/2026 PACTR Admin Control Group, Control group, For the control group (CG), no placebo or additional treatment will be administered., No placebo or additional treatment will be administered during the surgery. , The control group will receive standard care with no additional intervention., 21, Uncontrolled Control Group, Control, For the control group (CG), no placebo or additional treatment will be administered., No placebo or additional treatment will be administered during the surgery. , The control group will receive standard care with no additional intervention., 21, Uncontrolled