Comparative Efficacy of Combined Rocuronium -Atracurium in Patients Undergoing Day care abdominal Laparoscopic Surgery: A prospective, three arm, Randomized Controlled Study - nil

Start Date13 Jan 2026

Sponsor / Collaborator-

CTRI/2024/10/075144

/ Not yet recruitingNot ApplicableIIT

A prospective randomized study in comparing intubating conditions with and without priming with rocuronium - NIL

Start Date10 Sep 2025

Sponsor / Collaborator-

CTRI/2025/03/083133

/ Not yet recruitingNot ApplicableIIT

Comparision of intubating conditions of 4 times ED95 dose of rocuronium versus vecuronium during endotracheal intubation under general anesthesia-a prospective randamized double-blind study - NIL

Start Date07 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Rocuronium Bromide

100 Translational Medicine associated with Rocuronium Bromide

100 Patents (Medical) associated with Rocuronium Bromide

3,805

Literatures (Medical) associated with Rocuronium Bromide

01 May 2025·ANESTHESIA AND ANALGESIA

Rocuronium-Sugammadex Versus Cisatracurium-Neostigmine in Kidney Disease: Making Sense of Surprising Results

Article

Author: Dutton, Richard P.

01 May 2025·ANAESTHESIA AND INTENSIVE CARE

Perioperative anaphylaxis in Malaysia: A nine-year retrospective study

Article

Author: Bakhtiar, Mohammed-Faizal ; Hanim Binti Mohamad, Arfah ; Hui, Mun-Tsong ; Kwok, Fan-Yin ; Thomas Joseph, Cindy

Diagnosis of perioperative anaphylaxis (POA) and identification of causative agents remain challenging. This study aimed to describe the estimated incidence, characteristics and causative agents of POA in Malaysia. This is a retrospective review of all cases of suspected POA referred to the only anaesthetic allergy centre in Malaysia from March 2014 to December 2022. One hundred and ninety patients with suspected POA of Grade 2 and above were included. Data on clinical presentation, severity, management, serum tryptase and subsequent allergy workup (including skin and serum testing results) of these patients were extracted from the database. Dynamic tryptase was elevated in half of the cases where tryptase results were available and skin tests were positive in 96% of these cases. Skin testing was positive in 113 patients (60%) overall, and more than 70% of Grades 3 and 4 anaphylaxis cases. Neuromuscular blocking agents (NMBAs) and antibiotics were the most commonly identified causative agents (27.4% and 23% respectively). The commonest NMBAs were rocuronium and atracurium, both commonly cross-reacting with cisatracurium. The overall cross-reactivity rate among NMBAs was 58%. For antibiotics, the commonest causative agents were cefuroxime, ceftriaxone and amoxicillin/clavulanic acid. Using these data, the estimated incidence of Grades 2–4 POA over this period in Malaysia was approximately 1 in 30,000 anaesthetics. However, owing to the voluntary nature of reporting, it is possible that this is an underestimate, particularly in relation to some milder Grade 2 cases which may have gone unrecognised or unreported.

01 May 2025·ANESTHESIA AND ANALGESIA

Risk of Acute Complications with Rocuronium versus Cisatracurium in Patients with Chronic Kidney Disease: A Propensity-Matched Study

Article

Author: Kinsky, Michael P. ; Georgakis, Nikolas A. ; Arango, Daniel ; Gomez, Jonathon I. ; DeShazo, Sterling J.

BACKGROUND::

Neuromuscular blocking agents (NMBAs) play an integral role in modern anesthesia by facilitating endotracheal tube placement, assisting with mechanical ventilation, and creating optimal surgical conditions. However, NMBAs can have deleterious side effects. The purpose of this study was to retrospectively analyze acute complications of 2 pharmacodynamically similar but pharmacokinetically different NMBAs and their respective reversal agents.

METHODS::

The global research network database, TriNetX, was used to evaluate deidentified patient information from 63 health care organizations. Cohort A was defined as patients aged 18 to 80 years who had chronic kidney disease (CKD) and were administered rocuronium with sugammadex. Cohort B was defined as patients aged 18 to 80 years who had CKD and were administered cisatracurium with neostigmine. Cohorts were propensity matched for age at event, ethnicity, race, sex, and relevant confounding pathologies. All outcomes besides mortality were analyzed from the same day to 1 week after administration of the indexed drug. Mortality was analyzed from the same day to thirty days after administration of the indexed drug.

RESULTS::

A total of 95,740 patients with CKD-administered rocuronium with sugammadex were matched with 10,708 patients with CKD-administered cisatracurium with neostigmine. Patients administered rocuronium with sugammadex had a significantly higher associated risk of respiratory failure (risk ratios [RR], 1.98, confidence interval [CI], 1.71–2.29, P < .0001), acute respiratory distress (RR, 2.70, CI, 1.31–5.58, P = .0052), hypertensive crisis (RR, 1.85, CI, 1.37–2.49, P < .0001), heart failure (RR, 1.14, CI, 1.06–1.23, P = .0004), pleural effusion (RR, 1.30, CI, 1.14–1.49, P < .0001), and 30-day mortality (RR, 1.31, CI, 1.10–1.56, P = .0021).

CONCLUSIONS::

From 2003 to 2023, patients who were administered rocuronium plus sugammadex were at a significantly higher risk for acute cardiovascular and pulmonary complications when compared to patients who were administered cisatracurium plus neostigmine.

News (Medical) associated with Rocuronium Bromide

03 Dec 2024

·www.prnewswire.com

75% of Hospitals Face Medication Shortages - Germfree and On Demand Pharmaceuticals Partner to Deliver Localized Production Solutions

Partners working to expand program after successful six-month pilot study at North Mississippi Medical Center, which enabled production of 12,000 doses of multiple drugs in limited supply ORMOND BEACH, Fla., Dec. 3, 2024 /PRNewswire/ -- Germfree Laboratories, On Demand Pharmaceuticals (ODP), and North Mississippi Medical Center-Tupelo (NMMC) have teamed up to address the global drug shortage crisis with a groundbreaking point-of-care medicine production solution. The expanding partnership aims to bring agile production of essential medicines closer to the point of care across the country and globally, ensuring a reliable supply of life-saving drugs. Continue Reading Pharmacy staff monitoring pharmacy operations digitally With more than 75% of U.S. hospitals facing medication shortages and millions of people in low- and middle-income countries lacking access to critical medicines, the need for localized, flexible production is urgent. By combining Germfree's mobile cleanroom technology with ODP's Pharmacy on Demand platform, this collaboration empowers healthcare providers to produce high-quality medications on site, reducing reliance on fragile global supply chains. The partnership builds on a six-month pilot study that leveraged ODP's platform technology and Germfree's mobile cleanroom capability to produce syringes of common shortage medicines at NMMC, including lidocaine, rocuronium, and potassium chloride. This real-world pilot met all regulatory requirements, leveraged a state-of-the art quality management approach, and demonstrated a novel, agile compounding capability for drugs on shortage. It resulted in patients being treated with high-quality medicines that were made on-demand and on-site. "We're not just filling gaps in the supply chain, we're redefining it," said Kevin Kyle, CEO of Germfree. "With On Demand Pharma, we are enabling healthcare providers to meet patient needs faster and more reliably, whether in urban centers or rural areas. This partnership also demonstrates our commitment to using cutting-edge technologies to improve the way hospital pharmacies respond to the needs of their patients, with more to come." Matt Pietras, CEO of On Demand Pharmaceuticals, added, "This collaboration with Germfree provides us with the high-quality modular infrastructure needed to provide our Medication-as-a-Service (MaaS) where patients and healthcare providers need it most." The innovative model will allow hospitals like NMMC to produce critical medications locally, improving access for patients and ensuring continuity of care even during global supply disruptions. "Our pilot work completed through this collaboration has proven these new capabilities for on-site compounded medications are able to help us better serve our communities in a timelier manner," said Wes Pitts, System Director of Pharmacy at North Mississippi Health Services, which includes NMMC in Tupelo. "In our pilot program, we were able to successfully compound approximately 12,000 doses of shortage medications starting in December 2023 following regulations from the Board of Pharmacy." "We are on the cusp of expanding distributed medicine production through our network while creating a new paradigm," said John Lewin, Chief Medical Officer at ODP. "I envision a future where pharmacists take a leading role in medicine production – both today and as personalized medicine becomes the standard at the point of care." The collaboration between Germfree and On Demand Pharmaceuticals is set to transform the future of medicine accessibility by providing healthcare providers with the tools to produce medications on demand, whenever and wherever they are needed. About Germfree Laboratories: Germfree Laboratories is a global leader in cleanroom and critical environment technologies, specializing in providing innovative solutions for biopharmaceutical, healthcare, and research sectors. Learn more at . About On Demand Pharmaceuticals: On Demand Pharmaceuticals (ODP) is revolutionizing pharmaceutical access with its Pharmacy on Demand platform, offering agile, on-site production of medications. ODP is committed to overcoming industry barriers and ensuring high-quality medicines are accessible to all. Learn more at . About North Mississippi Medical Center: North Mississippi Medical Center (NMMC) is one of the largest non-metropolitan hospitals in the U.S., providing comprehensive medical services to a growing community. NMMC is committed to innovation in healthcare delivery to ensure high-quality, accessible care for its patients. For more information, visit . SOURCE Germfree Laboratories LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

27 Feb 2024

·www.biospace.com

Merck’s Bridion Could Face Generic Pressure from Hikma Ahead of Patent Expiry Date

Pictured: Merck research laboratories in California/iStock, hapabapa Merck in an SEC filing disclosed on Monday that Hikma Pharmaceuticals U.S. is seeking the FDA’s approval for its generic version of the muscle relaxant reversal injection Bridion (sugammadex) prior to the drug’s patent expiration. Hikma notified Merck of its intention on Feb. 5, 2024, according to the SEC filing. The British pharma is making its regulatory request under the Hatch-Waxman Act—also known as the Drug Price Competition and Patent Term Restoration Act of 1984—which established the approval pathway for generics. Specifically, Hikma is seeking approval for its Bridion copycat through a Paragraph IV Patent Certification letter, which according to the FDA’s website allows the approval of generics given that the patent for its reference product is “invalid, unenforceable, or will not be infringed by the generic product.” Under the Paragraph IV process, Merck has 45 days from being notified of the patent challenge to infringement suit against Hikma. While the court resolves the complaint, the FDA’s approval for the generic product is generally postponed for 30 months, unless the patent expires or a judge decides against the patent holder before then. Merck is “currently considering its options,” according to its SEC filing. Bridion is a modified gamma cyclodextrin that works by diffusing through the patient’s plasma and capturing the neuromuscular blocking agents rocuronium and vecuronium. The injectable drug first won the FDA’s approval in 2015 for use in adults undergoing surgery. It carries warnings against anaphylaxis and bradycardia, while its most common adverse events include vomiting, pain and nausea. The drug is one of Merck’s top-selling assets—and is still showing signs of growth. In 2023, Bridion brought in a little more than $1.84 billion, an increase from nearly $1.69 billion in revenue in 2022 and $1.53 billion in 2021, according to the SEC filing. In June 2023, the U.S. District Court for the District of New Jersey ruled in favor of Merck, finding that the company had correctly calculated its Patent Term Extension duration for Bridion. The court ruling protects Bridion from generic competition in the U.S. through at least January 2026. Bridion’s protections have already expired in the EU, in Japan and in China. At the time, Merck General Counsel Jennifer Zachary in a statement said that the decision will ultimately allow the company “to continue investing in research and development,” bringing new and innovative treatments to patients with unmet medical needs. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Patent InfringementDrug ApprovalPatent Expiration

27 Feb 2024

·www.biospace.com

Merck’s Bridion Could Face Generic Pressure from Hikma Ahead of Patent Expiry Date

Merck Research Laboratories in South San Francisco, California iStock, hapabapa Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version. Pictured: Merck research laboratories in California/iStock, hapabapa Merck in an SEC filing disclosed on Monday that Hikma Pharmaceuticals U.S. is seeking the FDA’s approval for its generic version of the muscle relaxant reversal injection Bridion (sugammadex) prior to the drug’s patent expiration. Hikma notified Merck of its intention on Feb. 5, 2024, according to the SEC filing. The British pharma is making its regulatory request under the Hatch-Waxman Act —also known as the Drug Price Competition and Patent Term Restoration Act of 1984—which established the approval pathway for generics. Specifically, Hikma is seeking approval for its Bridion copycat through a Paragraph IV Patent Certification letter, which according to the FDA’s website allows the approval of generics given that the patent for its reference product is “invalid, unenforceable, or will not be infringed by the generic product.” Under the Paragraph IV process, Merck has 45 days from being notified of the patent challenge to infringement suit against Hikma. While the court resolves the complaint, the FDA’s approval for the generic product is generally postponed for 30 months, unless the patent expires or a judge decides against the patent holder before then. Merck is “currently considering its options,” according to its SEC filing. Bridion is a modified gamma cyclodextrin that works by diffusing through the patient’s plasma and capturing the neuromuscular blocking agents rocuronium and vecuronium. The injectable drug first won the FDA’s approval in 2015 for use in adults undergoing surgery. It carries warnings against anaphylaxis and bradycardia, while its most common adverse events include vomiting, pain and nausea. The drug is one of Merck’s top-selling assets—and is still showing signs of growth. In 2023, Bridion brought in a little more than $1.84 billion, an increase from nearly $1.69 billion in revenue in 2022 and $1.53 billion in 2021, according to the SEC filing. In June 2023, the U.S. District Court for the District of New Jersey ruled in favor of Merck , finding that the company had correctly calculated its Patent Term Extension duration for Bridion. The court ruling protects Bridion from generic competition in the U.S. through at least January 2026. Bridion’s protections have already expired in the EU, in Japan and in China. At the time, Merck General Counsel Jennifer Zachary in a statement said that the decision will ultimately allow the company “to continue investing in research and development,” bringing new and innovative treatments to patients with unmet medical needs. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

Drug ApprovalPatent InfringementPatent Expiration

100 Deals associated with Rocuronium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
D00765	Rocuronium Bromide	M03AC09	DBSALT000575

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Indication	Country/Location	Organization	Date
Hyperemesis Gravidarum	China	Organon NV	07 Oct 2000
Anesthesia	United States	Organon USA, Inc.	17 Mar 1994

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Insufficiency	Phase 3	-	Merck Sharp & Dohme Corp.	01 Apr 2008
Voice Disorders	Phase 1	Canada	Merck Sharp & Dohme Corp.	01 Jul 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02631135 (CTgov)	Phase 4	-	40	Propofol+Rocuronium+Remifentanil (Group 1 (TIVA))	nwlbjikpxk(wrarjpylln) = xtijdrsntq khlbyuwpji (qpgcmrphgd, 1.31) View more	-	17 May 2024
				Dexmedetomidine+Propofol+Rocuronium+Remifentanil (Group 2 (TIVA+D))	nwlbjikpxk(wrarjpylln) = iqkethwjnf khlbyuwpji (qpgcmrphgd, 1.19) View more
NCT04512313 \| NCT03857750 (Pubmed)	Not Applicable	Anesthesia	50	Rocuronium 0.6 mg/kg	idwhymsurj(ftxomtbrrs) = xtmpsxrgtv ddqtktcwrz (gjtcgdzdov, 10 - 33)	-	13 May 2024
				Rocuronium 0.9 mg/kg	idwhymsurj(ftxomtbrrs) = lgwvfeimls ddqtktcwrz (gjtcgdzdov, 95% CI not provided)
NCT05343702 (Pubmed \| Rev Assoc Med Bras (1992))	Not Applicable	-	52	rocuronium (Standard rapid sequence intubation)	lfmodmizfz(mdvvhewzbo) = buaodhgxnj klhavaplpd (aiowpobcgp ) View more	Positive	01 Jan 2024
				Rocuronium priming	lfmodmizfz(mdvvhewzbo) = dvilxqgwjo klhavaplpd (aiowpobcgp ) View more
NCT03939923 (CTgov)	Phase 4	Coronary Artery Disease	84	Glycopyrrolate+Neostigmine+Rocuronium (Neostigmine/Glycopyrrolate)	cjtmkugfww(dugbkxxxhi) = clqhvlynmb rsgzkfgwee (ybiabdjlay, 5.9) View more	-	22 Dec 2023
				sugammadex+Rocuronium (Sugammadex)	cjtmkugfww(dugbkxxxhi) = xbsilsebsm rsgzkfgwee (ybiabdjlay, 4.7) View more
NCT03904550 (CTgov)	Phase 2	Renal Insufficiency	49	Cisatracurium+Neostigmine (Cisatracurium + Neostigmine)	upuuonvomj(jjvkkjhglt) = tkxmqcxvqz prbjyolonv (rfqjnndmau, 6.1) View more	-	03 Jul 2023
				sugammadex+Rocuronium (Rocuronium + Sugammadex)	upuuonvomj(jjvkkjhglt) = gpnnpgyezs prbjyolonv (rfqjnndmau, 1.6) View more
NCT03958201 (CTgov)	Phase 4	Paralysis	200	Rocuronium	kpxlfezvjs = nhzcozszvi kucefnhzzv (evrzivtkrg, jlmpmokayk - cdqkardhjj) View more	-	02 Nov 2022
Pubmed \| Eur J Anaesthesiol	Not Applicable	Myasthenia Gravis	1,143	Rocuronium reversed with sugammadex	sofkswopcs(lwlnemplvo) = ycxktiomjj kabqnvmwup (qfulzzvjcd )	Positive	01 Aug 2021
NCT04287426 (Pubmed \| Acta Anaesthesiol Scand)	Phase 4	-	78	Rocuronium 0.6 mg kg-1	rknfkspgxi(arollizvee) = nvcqxlgfla weaxuwfpyc (oqfxphyttz )	-	26 Jul 2021
				Remifentanil 2 µg kg-1	rknfkspgxi(arollizvee) = zhxaxuubqg weaxuwfpyc (oqfxphyttz )

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