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NCT Number: NCT07777835

Magnesium Sulphate With Atropine and Pralidoxime vs Standard Therapy Alone in Acute Organophosphate Poisoning

Pakistan, being a developing country, is one of the regions with the most cases of organophosphate (OP) poisoning/toxicity. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. This study is being carried out with the objective of comparing the 15-day all-cause mortality rate and the total cumulative atropine requirement during hospitalization between patients receiving adjunctive magnesium sulphate with standard therapy and those receiving standard therapy alone.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current standard therapy in OP is lacking in managing the Intermediate Syndrome (IMS) and the delayed complications. This deficiency underscores the need for carrying out research to test the efficacy of adjunct compounds in the better management of the toxicity of this deadly substance. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. In a setting where economic instability and a compromised health system put an uneven burden on the shoulders of the patient, introducing a regimen that could possibly reduce the hospital stay and prevent the use of ventilators can be very healthy for the pockets of the government bodies as well as the patient's attendants. Assessing atropine consumption, need for mechanical ventilation, incidence of respiratory failure due to IMS, length of hospital admission, and mortality in the treatment would enable clinicians to recognize whether the adjunctive treatment is efficacious in achieving reasonable outcomes or not.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders
  • Adult patients aged between 18 and 50 years
  • Confirmed clinical diagnosis of organophosphate poisoning containing insecticide, through the oral route
  • Adult patients, or their legally authorized representative, who will provide informed consent to participate in the study

Exclusion criteria

  • Patients with known allergy to MgSO4
  • Patients with documented pre-existing renal impairment (Serum creatinine more than 1.5mg/dl)
  • Patients with documented pre-existing cardiac impairments (e.g., heart block)
  • Pregnant or lactating women
  • Confirmed intake of any other drug or poison
  • Patients who will be declared dead on arrival or those who expired within 2 hours of presentation

Treatment and study plan

Atropine plus pralidoxime

Drug

Patients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours).

Atropine and pralidoxime with adjunctive MgSO4

Drug

Patients will be treated with standard atropine plus pralidoxime therapy alone.

Primary outcomes

  1. Mortality

    Time frame: 15 days after hospital admission

    Frequency of patients will be noted who will die within 15 days to clinical stabilization.

Secondary outcomes

  1. Intermediate Syndrome (IMS)

    Time frame: 7 days after poisoning

    Frequency of patients will be noted who will develop Intermediate Syndrome (IMS) within seven days of poisoning.

Study contacts

Contact information is provided by the study sponsor or research team.

Arif Mahmood, FCPS

CONTACT

[email protected]

+923008730810

Sana Usman

CONTACT

[email protected]

+923007154668

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Comparison of the Efficacy of Adjunctive Magnesium Sulphate With Standard Atropine and Pralidoxime Therapy vs Standard Therapy Alone in Acute Organophosphate Poisoning

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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