Post Operative Inflammatory Marker LevelsNCT07803601
Effect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery
A study testing Magnesium sulfate (MgSO4) and Normal Saline in people with Post Operative Inflammatory Marker Levels and Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Post Operative Inflammatory Marker Levels, Post Operative Pain
- What is being tested?
- Magnesium sulfate (MgSO4) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and ASA II.
- Age (35yrs - 75yrs).
- Patients undergoing open colorectal cancer surgery.
- Sex: Both sexes.
Who cannot join
- Renal impairment (Glomerular Filtration Rate < 60 ml\min).
- Severe cardiac dysfunction (Ejection fraction ≤ 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.
- Autoimmune disorders (eg: rheumatoid arthritis, multiple sclerosis and lupus), congenital and acquired immunodeficiency.
- Previous / current immunomodulatory therapy.
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- 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.
- Body mass index less than 18 or greater than 30 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nada sami abdelfattah mohammed, M.Sc. contact
Sherif Farouq Ibrahim El Shantory, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Abbassia, 00202
Nada sami abdelfattah mohammed, M.Sc., +201095640453 ext. +201119256004, NadaSamiAbdelfattah@med.asu.edu.eg
Sherif Farouq Ibrahim El Shantory, Professor, +201099811994, nadaelaidy1995@gmail.com
About this study
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.
- Being tested
- Magnesium sulfate (MgSO4), Normal Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate (MgSO4)Drug
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.
Normal SalineDrug
The patients will receive the same normal saline volume for loading and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| study group (magnesium sulfate group) | Active comparator | 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. Receives: Drug: Magnesium sulfate (MgSO4) |
| control group | Placebo comparator | The patients will receive the same normal saline volume for loading and maintenance. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative white blood cell count (WBC)
Assess effect of intravenous magnesium sulfate on postoperative inflammation by serum inflammatory marker as WBCS.
Measured: inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.
Secondary outcomes (7)
postoperative C-reactive protein (CPR)
Effect of intravenous magnesium sulfate on postoperative serum C-reactive protein level.
Measured: during 36 hrs postoperative.CRP will be measured at 2 time points: 12 and 36 hours after surgery.
postoperative neutrophil count
Effect of intravenous magnesium sulfate on postoperative neutrophil count.
Measured: 12 and 36 hours after surgery.
Time to recovery from anesthesia
time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.
Measured: immediately after surgery
Postoperative pain intensity
Postoperative pain intensity assessed using the visual Analog Scale (VAS).
Measured: During the first 36 hours postoperatively.
Time to first postoperative analgesic requirement
Time from extubation to the first postoperative administration of rescue analgesia.
Measured: During the first 36 hours postoperatively.
Cumulative postoperative nalbuphine consumption
total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h.
Measured: During the first 36 hours postoperatively.
Postoperative side effects as nausea, vomiting, bradycardia and hypotension
incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.
Measured: During the first 36 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Inflammatory Marker LevelsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803601
- Sponsor's protocol ID
- FMASU MD 30/2026
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07803601
- Acronym / sponsor ID
- FMASU MD 30/2026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Sep 2026 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (magnesium sulfate group) | Active comparator | Drug: Magnesium sulfate (MgSO4)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. |
| control group | Placebo comparator | Drug: Normal SalineThe patients will receive the same normal saline volume for loading and maintenance. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I and ASA II.
- Age (35yrs - 75yrs).
- Patients undergoing open colorectal cancer surgery.
- Sex: Both sexes.
Key exclusion criteria (11 listed)
- Renal impairment (Glomerular Filtration Rate < 60 ml\min).
- Severe cardiac dysfunction (Ejection fraction ≤ 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.
- Autoimmune disorders (eg: rheumatoid arthritis, multiple sclerosis and lupus), congenital and acquired immunodeficiency.
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 |
|---|---|---|
| Magnesium sulfate (MgSO4)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 | study group (magnesium sulfate group) |
| Normal SalineThe patients will receive the same normal saline volume for loading and maintenance. | Drug | control group |
Primary outcome
postoperative white blood cell count (WBC)
Time frame: inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.
Assess effect of intravenous magnesium sulfate on postoperative inflammation by serum inflammatory marker as WBCS.
7 secondary outcomes
postoperative C-reactive protein (CPR)
Time frame: during 36 hrs postoperative.CRP will be measured at 2 time points: 12 and 36 hours after surgery.
postoperative neutrophil count
Time frame: 12 and 36 hours after surgery.
Time to recovery from anesthesia
Time frame: immediately after surgery
Postoperative pain intensity
Time frame: During the first 36 hours postoperatively.
Time to first postoperative analgesic requirement
Time frame: During the first 36 hours postoperatively.
Cumulative postoperative nalbuphine consumption
Time frame: During the first 36 hours postoperatively.
Postoperative side effects as nausea, vomiting, bradycardia and hypotension
Time frame: During the first 36 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
Nada sami abdelfattah mohammed, M.Sc. contact
Sherif Farouq Ibrahim El Shantory, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate (MgSO4) and Normal Saline in people with Post Operative Inflammatory Marker Levels and Post Operative Pain, run by Ain Shams University 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 11 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada sami abdelfattah mohammed, M.Sc. (+201095640453 ext. +201119256004, NadaSamiAbdelfattah@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative white blood cell count (WBC) (time frame: inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.