Cisatracurium Besylate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate Cisatracurium Besylate in neuromuscular blockade management, focusing on conditions including prolonged neuromuscular block, residual neuromuscular curarization, and postoperative nausea and vomiting. Encompassing both completed and recruiting studies classified as Phase Not Applicable, these trials are sponsored by academic and medical institutions such as Al Safwa University College, Poitiers University Hospital, and The Second Hospital of Anhui Medical University. Protocols investigate physical recovery parameters, residual blockade monitoring, and related postoperative symptoms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05657756	Recruiting	Neuromuscular Block Prolonged	Al Safwa University College	2023-06-01	Not Applicable
NCT05231525	Completed	Neuromuscular Residual Curarization	Poitiers University Hospital	2022-03-09	Not Applicable
NCT05240482	Completed	Postoperative Nausea and Vomiting	The Second Hospital of Anhui Medical University	2022-02-20	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cisatracurium Besylate is a nondepolarizing neuromuscular junction blocker that competitively binds to nicotinic acetylcholine receptors, thereby blocking acetylcholine-mediated neurotransmission and preventing motor end-plate depolarization. This inhibition suppresses downstream skeletal muscle excitation-contraction coupling to induce flaccid muscle relaxation, directly providing the therapeutic effect evaluated in clinical conditions such as prolonged neuromuscular block and residual curarization.

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>).