Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial

This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.

Start Date06 Nov 2024

Sponsor / Collaborator

Seoul National University Hospital

CTRI/2024/10/075208

/ Not yet recruitingPhase 4IIT

Comparison of emergence from general anaesthesia in microlaryngeal surgery using rocuronium and sugammadex with succinylcholine, cisatracurium and neostigmine: a prospective randomized controlled trial - NIL

Start Date24 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Rocuronium Bromide

100 Translational Medicine associated with Rocuronium Bromide

100 Patents (Medical) associated with Rocuronium Bromide

3,793

Literatures (Medical) associated with Rocuronium Bromide

01 Apr 2025·ANESTHESIA AND ANALGESIA

Use of Sugammadex in “Cannot Intubate, Cannot Ventilate” Scenarios: A Systematic Review of Case Reports

Article

Author: Kaddoum, Roland N. ; Serhan, Fatima G. ; Sokhn, Anthony M. ; Khalili, Amro F. ; Abou Nafeh, Nancy G. ; Aouad, Marie T.

After an induction dose of rocuronium, sugammadex in a dose of 16 mg.kg−1 has been shown to provide early reversal of the neuromuscular blockade. However, the use of sugammadex to rescue a “cannot intubate, cannot ventilate” (CICV) scenario remains controversial. The aim of this systematic review was to discuss case reports describing the use of sugammadex as a rescue reversal in CICV scenarios and analyze the influencing factors potentially shaping the outcome of such reversal. The study has been registered on International Prospective Register of Systematic Reviews (PROSPERO) (CRD42024514255). We conducted a systematic review of the literature using PubMed, Medline, and Embase. Records were included if they were case reports or case series published in peer-reviewed journals, describing the administration of sugammadex as a rescue reversal in CICV scenarios, and including clinical outcomes and details of the management. Sources were last searched on November 30, 2023. The articles selected were initially screened based on their titles and abstracts, and then complete articles were examined to determine their eligibility and compliance with the inclusion criteria. Two independent authors evaluated the quality of the individual studies using the Joanna Briggs Institute Critical Appraisal Checklist for Case Reports. Eight articles were included in our review. In all patients, CICV scenarios were declared minutes following induction. In 6/8 cases (75%), adequate spontaneous ventilation was restored after the administration of sugammadex. In the remaining 2 cases, sugammadex administration resulted in an obstructed pattern of breathing, and surgical airway was the successful rescue technique. There was wide variability in the sugammadex dose with a median (range) of 14 (5–16) mg.kg−1 and median timing (range) from rocuronium administration of 6 (2–10) minutes.This case-report-based review is susceptible to reporting bias and may not encompass all pertinent data and adverse events. Also, cases with both favorable and unfavorable outcomes may have not been published, and the heterogeneity of cases limits the ability to draw definitive conclusions. In summary, although these case reports suggest that sugammadex might be helpful in CICV scenarios, further research is needed to confirm its effectiveness. However, due to the rare occurrence of CICV events, gathering sufficient data for conclusive evidence may be challenging.

01 Apr 2025·PEDIATRIC ANESTHESIA

Case Series of Anesthetic Management of Gene Therapy in Children With Aromatic L‐Amino Acid Decarboxylase Deficiency

Article

Author: Vayssiere, Pia ; Ravelli, Claudia ; Goetz, Laurent ; Devys, Jean‐Michel ; D'Hardemare, Vincent ; Boulloud, Christophe ; Dorison, Nathalie ; Bonheur, Julie ; Clariot, Simon ; Gras, Séverine

ABSTRACT:

Background:

Aromatic L‐amino acid decarboxylase (AADC) deficiency is a rare life‐threatening inborn error of neurotransmitter biosynthesis. It is characterized by deficient biosynthesis of neurotransmitters dopamine and serotonin, leading to catecholamines deficiency and sympathetic deprivation, while the parasympathetic system remains functional. Since 2012, gene therapy has led to clinical improvements in symptoms and motor function with a severe phenotype. General anesthesia of children with AADC deficiency is challenging.

Aim:

Describe prolonged anesthesia management of children with aromatic L‐amino acid decarboxylase deficiency undergoing stereotactically guided gene therapy.

Methods:

Prospective reporting of epidemiologic and anesthetics data of four children consecutively undergoing magnetic resonance‐guided direct delivery of an AADC vector for gene therapy under general anesthesia.

Results:

General anesthesia was initiated with sevoflurane and ketamine and rocuronium was the neuromuscular blocking agent of choice throughout the procedures. Intraoperative hemodynamic monitoring included an arterial line. All children required low doses of diluted norepinephrine during the intraoperative period. No dysautomic episodes as well as no episode of severe hypotension and no severe hypoglycemia were reported throughout the procedures. Vasopressor support was discontinued for all children at the end of the procedures. Moreover, no peroperative and postoperative effects secondary to AADC vector injection were noted.

Conclusion:

Using an anesthetic plan based on atropine, ketamine, sevoflurane, and a titrated infusion of norepinephrine, prolonged anesthesia appeared to be safe and reproductible in this population.

01 Apr 2025·Anaesthesia Critical Care & Pain Medicine

Reversing aminosteroid neuromuscular blocking drugs with sugammadex — Pipecuronium, rocuronium and vecuronium are not the same

Author: Bowdle, Andrew ; Thilen, Stephan R

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

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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))	sbsdbsakif(bstbsnptpv) = rctqdbfkaw xdvgtmulsf (ufvquipgbi, 1.31) View more	-	17 May 2024
				Dexmedetomidine+Propofol+Rocuronium+Remifentanil (Group 2 (TIVA+D))	sbsdbsakif(bstbsnptpv) = meirulrhtv xdvgtmulsf (ufvquipgbi, 1.19) View more
NCT04512313 \| NCT03857750 (Pubmed)	Not Applicable	Anesthesia	50	Rocuronium 0.6 mg/kg	twaifazwnl(ecpoenhmkj) = hbgabwsetb mcwsuwgxou (vjrichcchp, 10 - 33)	-	13 May 2024
				Rocuronium 0.9 mg/kg	twaifazwnl(ecpoenhmkj) = yscibvmtxi mcwsuwgxou (vjrichcchp, 95% CI not provided)
NCT05343702 (Pubmed \| Rev Assoc Med Bras (1992))	Not Applicable	-	52	rocuronium (Standard rapid sequence intubation)	glrwlpomxb(netnxrsrli) = sjpsxcvnrb kptlshnhkt (nvbvbxrexl ) View more	Positive	01 Jan 2024
				Rocuronium priming	glrwlpomxb(netnxrsrli) = prfmfqapnf kptlshnhkt (nvbvbxrexl ) View more
NCT03939923 (CTgov)	Phase 4	Coronary Artery Disease	84	Glycopyrrolate+Neostigmine+Rocuronium (Neostigmine/Glycopyrrolate)	zphhxdprjn(vsuvvhrkfa) = gpnjcimffi ccnkfjsqiw (zqlexmbozz, 5.9) View more	-	22 Dec 2023
				sugammadex+Rocuronium (Sugammadex)	zphhxdprjn(vsuvvhrkfa) = qtxceaaewm ccnkfjsqiw (zqlexmbozz, 4.7) View more
NCT03904550 (CTgov)	Phase 2	Renal Insufficiency	49	Cisatracurium+Neostigmine (Cisatracurium + Neostigmine)	tjjktibiug(wcxkxoumbf) = nqmnoehyer fdbeokrzbr (btmhlituva, 6.1) View more	-	03 Jul 2023
				sugammadex+Rocuronium (Rocuronium + Sugammadex)	tjjktibiug(wcxkxoumbf) = orkylehvyd fdbeokrzbr (btmhlituva, 1.6) View more
NCT03958201 (CTgov)	Phase 4	Paralysis	200	Rocuronium	gumhrvavmm = spqgpsqvrm olhinfcjfo (bflnvljpmd, njatltnnkw - lufpmgwgtl) View more	-	02 Nov 2022
Pubmed \| Eur J Anaesthesiol	Not Applicable	Myasthenia Gravis	1,143	Rocuronium reversed with sugammadex	zldqrbaeii(koadaytfbf) = rxqffbvqbo vezftuifcq (dzzalliqfa )	Positive	01 Aug 2021
NCT04287426 (Pubmed \| Acta Anaesthesiol Scand)	Phase 4	-	78	Rocuronium 0.6 mg kg-1	cmamnhyrty(igcbdntcpn) = rkdisnyokw branldjrtc (ilmfhzcxxj )	-	26 Jul 2021
				Remifentanil 2 µg kg-1	cmamnhyrty(igcbdntcpn) = fjpjjtekpn branldjrtc (ilmfhzcxxj )

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