NCT07803601

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2026Apr 2027

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 27, 2026

Last Update Submit

September 2, 2026

Conditions

Post Operative Inflammatory Marker LevelsPost Operative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative white blood cell count (WBC)

    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 Outcomes (7)

  • postoperative C-reactive protein (CPR)

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

  • postoperative neutrophil count

    12 and 36 hours after surgery.

  • Time to recovery from anesthesia

    immediately after surgery

  • Postoperative pain intensity

    During the first 36 hours postoperatively.

  • Time to first postoperative analgesic requirement

    During the first 36 hours postoperatively.

  • +2 more secondary outcomes

Study Arms (2)

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.

Drug: Magnesium sulfate (MgSO4)

control group

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Normal SalineDRUG

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

control group
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.

study group (magnesium sulfate group)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Abbassia, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Nada sami abdelfattah mohammed, M.Sc.

CONTACT

+201095640453NadaSamiAbdelfattah@med.asu.edu.eg

Sherif Farouq Ibrahim El Shantory, Professor

CONTACT

+20199811994

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Locations

EG(1)