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

September 2, 2026 updated by: Ain Shams University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sherif Farouq Ibrahim El Shantory, Professor
  • Phone Number: +20199811994

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 00202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.
Placebo Comparator: control group
The patients will receive the same normal saline volume for loading and maintenance.
Drug: Normal Saline
The patients will receive the same normal saline volume for loading and maintenance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Effect of intravenous magnesium sulfate on postoperative serum C-reactive protein level.
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.
Effect of intravenous magnesium sulfate on postoperative neutrophil count.
12 and 36 hours after surgery.
Time to recovery from anesthesia
Time Frame: immediately after surgery
time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.
immediately after surgery
Postoperative pain intensity
Time Frame: During the first 36 hours postoperatively.
Postoperative pain intensity assessed using the visual Analog Scale (VAS).
During the first 36 hours postoperatively.
Time to first postoperative analgesic requirement
Time Frame: During the first 36 hours postoperatively.
Time from extubation to the first postoperative administration of rescue analgesia.
During the first 36 hours postoperatively.
Cumulative postoperative nalbuphine consumption
Time Frame: During the first 36 hours postoperatively.
total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h.
During the first 36 hours postoperatively.
Postoperative side effects as nausea, vomiting, bradycardia and hypotension
Time Frame: During the first 36 hours postoperatively.
incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.
During the first 36 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MD 30/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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