Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

Phase 3

Active, not recruiting

• Conditions: Pesticide Poisoning; Anticholinesterase Insecticide Poisoning
• Interventions: Drug: Magnesium Sulfate; Drug: Nimodipine

• Registration Number: NCT03925025
• Lead Sponsor: University of Edinburgh

Brief Summary

This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-23
• Study Start: 2020-06-11
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3243

Inclusion Criteria

• Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
• Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
• Patients who ingest combination products containing OP or carbamate insecticides will also be included.
• Inhibited blood cholinesterase activity as shown by routine clinical bedside test

Exclusion Criteria

• Children aged <16 years.
• Patients who do not require atropine and have not had it prior to presentation during this episode.
• Normal blood cholinesterase activity
• Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
• Known occupational and homicidal poisoning
• Past medical history of severely impaired renal function
• Hypersensitivity to magnesium and its salts
• Patients who have had a myocardial infarction or unstable angina in the last month
• Patients with traumatic subarachnoid haemorrhage
• Lack of informed consent (unaccompanied unconscious patients and others)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulfate	Magnesium Sulfate	Standard therapy plus magnesium sulfate
Nimodipine	Nimodipine	Standard therapy plus nimodipine

Primary Outcome Measures

Name	Time	Method
Mortality	through to hospital discharge, median 1 week	Whether dead or alive at hospital discharge

Trial Locations

Locations (7)

Chattogram Medical College Hospital; 🇧🇩 Chittagong, Bangladesh

Jashore Medical College Hospital; 🇧🇩 Jessore, Bangladesh

Shaheed Ziaur Rahman Medical College; 🇧🇩 Bogra, Silimpur, Bangladesh

Rajshahi Medical College Hospital; 🇧🇩 Rājshāhi, Rajshahi, Bangladesh

Khulna Medical College Hospital; 🇧🇩 Khulna, Bangladesh

Sylhet MAG Osmani Medical College Hospital; 🇧🇩 Sylhet, Bangladesh

Rangpur Medical College Hospital; 🇧🇩 Rangpur, Bangladesh