Atropine sulfate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed clinical trial sponsored by Universitätsklinikum Hamburg-Eppendorf evaluated atropine sulfate for airway management, tracheal intubation, and heart rate regulation. Lacking a formal phase designation, the study investigated whether intubation-triggered heart rate decreases serve as predictive indicators for intraoperative bradycardia during procedures such as microlaryngoscopy. Overall, the trial highlights the ongoing focus on hemodynamic monitoring and cardiovascular stability during perioperative airway instrumentation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05160207	Completed	Tracheal Intubation\|Airway Management\|Heart Rate	Universitätsklinikum Hamburg-Eppendorf	2021-11-04	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Atropine sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atropine sulfate acts as a competitive antagonist of muscarinic acetylcholine receptors, thereby blocking parasympathetic cholinergic signaling and inhibiting downstream G-protein-mediated biochemical cascades. This receptor blockade counteracts vagal tone to elevate heart rate and reduce salivary and bronchial secretions, demonstrating direct clinical relevance for managing heart rate during airway management and preventing intraoperative bradycardia associated with tracheal intubation.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).