Clinical Trials

Multiple clinical trials evaluate the clinical applications and management protocols associated with succinylcholine chloride dihydrate, primarily investigating neuromuscular blockade, suxamethonium sensitivity, gastric content aspiration, drug onset timing during rapid sequence induction, and neuromuscular monitoring strategies. Featuring completed or unknown recruitment statuses across unassigned or non-applicable phases, these studies are sponsored by academic medical centers and industry organizations, including University Hospital Caen, Herlev Hospital, and Merck Sharp & Dohme LLC.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03415607 Unknown status
Suxamethonium Sensitivity|Aspiration of Gastric Contents Into Respiratory Tract Part Unspecified
University Hospital Caen
2017-11-06 --
NCT02925143 Completed
Neuromuscular Blockade
Herlev Hospital|Merck Sharp & Dohme LLC
2016-11-21 Not Applicable

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

Check the Succinylcholine Chloride Dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Succinylcholine chloride dihydrate acts as a nicotinic acetylcholine receptor agonist that binds to post-junctional receptors at the neuromuscular junction, inducing sustained motor end-plate depolarization and persistent muscle cell refractory states. This depolarizing blockade prevents subsequent synaptic excitation and leads to rapid flaccid paralysis, providing the physiological basis for its clinical utility in achieving neuromuscular blockade during rapid sequence induction to protect against pulmonary aspiration.

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>).

Note: Technical data last updated: Sep 1, 2026.