ClinicalTrials.gg
RecruitingNCT07803601Updated Sep 3, 2026

Effect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery

An interventional study of Magnesium sulfate (MgSO4) and Normal Saline in Post Operative Inflammatory Marker Levels and Post Operative Pain, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2026, registered Aug 2026).
  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 102 studies in Pain, Postoperative by Ain Shams University — 24 open to participants now, 28 under way, 2 of them phase 3. Pain, Postoperative · Ain Shams University.

Planned enrollment
64th of 100
52 · median 60
Started
2026
with 8 others
No phase
62 of 102
15 open now
Primary completion
2027-03
later than 23 of 27 live
Registered
100th of 102
by date

Among the 102 studies in Pain, Postoperative by Ain Shams University, this one is the 64th largest by planned enrollment of the 100 interventional ones, is one of 9 that started in 2026, is one of 62 with no phase, reaches primary completion later than 23 of the 27 other live ones, and was the 100th registered.

By phase

102 studies; the count open now beside each. This study's row is marked.

No phasethis study62 · 15 open
Phase 114 · 5 open
Phase 414 · 1 open
Phase 35 · 1 open
Observational2 · 0 open
Phase 1/22 · 0 open
Phase 22 · 1 open
Phase 2/31 · 1 open

By the year they started

First in 2013; this study’s year is marked. 9 started in 2026.

Size and results

Median enrollment 60 across the 100 interventional studies, 128 across the 2 observational. Of the 63 that completed or were terminated, 3 (5%) have results posted.

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02

Study summary

The aim of this study is to detect the effect of intraoperative intravenous magnesium sulfate on postoperative systemic inflammatory response by serum inflammatory parameters as CRP, WBCS and neutrophil count.

Read the detailed description

The aim of this study is to detect the effect of intraoperative intravenous magnesium sulfate on postoperative systemic inflammatory response by serum inflammatory parameters as CRP, WBCS and neutrophil count. In the anesthesia clinic, an informed written consent will be taken from every patient one day before the surgery. Anesthesia will be provided according to the hospital protocol in respect to preoperative investigations, fasting hours and intra-operative monitoring and drugs. VAS score will be explained to the patient and how to express pain intensity with the use of Visual Analogue Scale (VAS); 10 cm unmarked line in which 0=no pain, 10 cm= the worst imaginable pain. All patients will be clinically assessed and standard preoperative investigations will be done; Complete Blood Count, Coagulation profile, liver function tests, kidney function tests, CRP, chest x-ray and ECG. Intraoperative monitoring items included non-invasive blood pressure (NIBP), heart rate (HR), electrocardiography (ECG), pulse oximetry (Spo2), end-tidal CO2 (EtCo2) and urine output (UOP). Pre-induction hemodynamic parameters (heart rate and mean arterial pressure) will be recorded. General anesthesia will be encouraged with propofol (2 mg/kg) IV followed by atracurium 0.5 mg/kg IV and fentanyl 1 ug/kg. After 3 minutes, intubation will be done. Anesthesia will be maintained with isoflurane 1% MAC in oxygen, air and atracurium 0.1 mg/kg. After the induction of anesthesia, For the patients in group A (study group) (26 patients), a bolus dose of magnesium sulfate (50 mg/Kg over 20 minutes) will be administered then, the maintenance dose of magnesium sulfate (15mg/Kg/hour) will be infused till the end of the surgery. In group B (control group) (26 patients), the patients will receive normal saline with the same volume and the same infusion model. The study drug (MgSO4) and the placebo (normal saline) will be prepared in the hospital pharmacy. Each one will be assigned a code so that the anesthetist will remain blinded to group allocation. Intravenous fentanyl infusion 0.4µg/kg/hr will be administrated during intraoperative period till the end of surgery. At the end of surgery, inhalational anesthetics will be discontinued and muscle relaxant will be reversed by intravenous atropine 10 μg/kg and neostigmine 0.05 mg/kg. In both groups, hemodynamic parameters as heart rate and mean blood pressure (MAP) will be continuously monitored till the end of surgery in addition that urine output (UOP) will be frequently monitored and recorded. If heart rate becomes less than 50 bpm, 0.5 mg IV atropine will be given. 10 mg IV ephedrine will be given if mean arterial pressure becomes less than 60 mmHg. Time of recovery (time period from stopping the anesthetic drug administration and the surgical process has been completed to extubation) will be measured in each group.

03

Conditions studied

  • Post Operative Inflammatory Marker Levels
  • Post Operative Pain

Browse trials for

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • and ASA II.
  • Age (35yrs - 75yrs).
  • Patients undergoing open colorectal cancer surgery.
  • Sex: Both sexes.

Exclusion criteria

Exclusion Criteria:

  • Renal impairment ( \< 60 ml\min).
  • Severe cardiac dysfunction ( ≤ 30% or clinical signs and symptoms of reduced left ventricular ejection fraction), preoperative bradycardia (HR \< 50 bpm) and atrioventricular block (first, second and third degree).
  • Allergy to study drug (MgSO4).
  • Patient refusal to precipitate in this study.
  • disorders (eg: rheumatoid arthritis, multiple sclerosis and lupus), congenital and acquired immunodeficiency.
  • Previous / current immunomodulatory therapy.
  • Emergency condition (eg: obstruction or perforation in colorectal cancer).
  • Postoperative complications altering inflammatory response (eg: infection, anastomotic leak).
  • Duration of operation > 5 hours.
  • Cognitive impairment (eg: Dementia) and other psychiatric disorders by history.
  • less than 18 or greater than 30 kg/m².
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    study group (magnesium sulfate group)

    After the induction of anesthesia, the patients will receive loading intravenous magnesium sulfate (50mg/kg over 20 minutes) and maintenance (15mg/kg/hr) till the end of surgery.

    Drug: Magnesium sulfate (MgSO4)

  • Placebo comparator
    control group

    The patients will receive the same normal saline volume for loading and maintenance.

    Drug: Normal Saline

Interventions

  • After the induction of anesthesia, the patients will receive loading intravenous magnesium sulfate (50mg/kg over 20 minutes) and maintenance (15mg/kg/hr) till the end of surgery.

  • DrugNormal Saline

    The patients will receive the same normal saline volume for loading and maintenance.

06

What researchers measure

Primary outcomes

  1. postoperative white blood cell count (WBC)

    Assess effect of intravenous magnesium sulfate on postoperative inflammation by serum inflammatory marker as WBCS.

    Time frame: inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.

Secondary outcomes

  1. postoperative C-reactive protein (CPR)

    Effect of intravenous magnesium sulfate on postoperative serum C-reactive protein level.

    Time frame: during 36 hrs postoperative.CRP will be measured at 2 time points: 12 and 36 hours after surgery.

  2. postoperative neutrophil count

    Effect of intravenous magnesium sulfate on postoperative neutrophil count.

    Time frame: 12 and 36 hours after surgery.

  3. Time to recovery from anesthesia

    time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.

    Time frame: immediately after surgery

  4. Postoperative pain intensity

    Postoperative pain intensity assessed using the visual Analog Scale (VAS).

    Time frame: During the first 36 hours postoperatively.

  5. Time to first postoperative analgesic requirement

    Time from extubation to the first postoperative administration of rescue analgesia.

    Time frame: During the first 36 hours postoperatively.

  6. Cumulative postoperative nalbuphine consumption

    total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h.

    Time frame: During the first 36 hours postoperatively.

  7. Postoperative side effects as nausea, vomiting, bradycardia and hypotension

    incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.

    Time frame: During the first 36 hours postoperatively.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 3, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07803601
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Mar 1, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Nada sami abdelfattah mohammed, M.Sc.
Contact
NadaSamiAbdelfattah@med.asu.edu.eg
+201095640453 ext. +201119256004
Sherif Farouq Ibrahim El Shantory, Professor
Contact
+20199811994

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Magnesium sulfate anhydrous

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