Rocuronium Bromide Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated the therapeutic application of rocuronium bromide in surgical anesthesia and lumbar spinal stenosis management. These completed studies comprise an Early Phase 1 trial sponsored by the Second Hospital of Shanxi Medical University investigating how paravertebral muscle fat infiltration impacts rocuronium requirements during lumbar surgery, as well as a Phase 3 trial sponsored by Merck Sharp & Dohme LLC evaluating comparative safety and anesthetic efficacy. Together, these trials demonstrate the agent's established role in perioperative patient care.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05619848	Completed	Spinal Stenosis Lumbar	Zheng Guo\|Second Hospital of Shanxi Medical University	2022-10-25	Early Phase 1
NCT00675792	Completed	Anesthesia	Merck Sharp & Dohme LLC	2008-05	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rocuronium bromide competitively binds to nicotinic acetylcholine receptors at the motor endplate of the neuromuscular junction, thereby preventing endogenous acetylcholine from triggering postsynaptic membrane depolarization. This competitive inhibition prevents muscle cell action potentials and muscle fiber contraction to produce rapid skeletal muscle relaxation, providing essential neuromuscular blockade for endotracheal intubation and surgical procedures under general anesthesia.

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>).