CLINICAL TRIALS PROFILE FOR ATRACURIUM BESYLATE

All Clinical Trials for atracurium besylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02861716 ↗	Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine in Children Undergoing Major Abdominal Cancer Surgery	Unknown status	South Egypt Cancer Institute	Phase 2	2016-08-01	In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.
NCT03005860 ↗	Effect of TIVA Propofol vs Sevoflurane Anaesthetic on Serum Biomarkers and on PBMCs in Breast Cancer Surgery	Unknown status	Tata Memorial Centre	N/A	2017-02-01	Surgery, perioperative stress, anaesthetics and analgesics may modulate the immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance between immunity & carcinogenesis. This may lead to escape of cancer cells and tilt the scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a favorable profile and inhibits cancer cell activity. Determining "cancer-protective" role of TIVA with propofol presents an exciting window of opportunity that has potential to improve outcomes in cancer patients undergoing resection surgery
NCT03052673 ↗	Ketamine for Pain Relief in Bariatric Surgery	Completed	Sir Ganga Ram Hospital	Phase 4	2017-02-20	The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve gastrectomy are collectively covered under the term 'bariatric surgery'. The growth of bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure patient safety and facilitate post-surgery outcome. Conventionally, balanced general anaesthesia techniques routinely use opioids peri-operatively for intra-operative haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the same technique when employed in the morbidly obese patients hampers early and intermediate postoperative recovery due to the occurrence of side effects, such as, sedation, PONV, respiratory depression, depressed GI-mobility. The above stated side effects, have lead to increased propensity for postoperative cardiac and pulmonary complications. Obese patients are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be employed judiciously in these patients. On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimise opioid use and employ some other drugs which besides having analgesia, has a opioid-sparing effect also. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key advantage of ketamine is that it can reduces post-operative pain and use of opioid when used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to decrease opioid-related postoperative morbidity in these patients undergoing bariatric surgery.In view of the above, a clinical research is highly desirable to study techniques to decrease the use of opioids in obese surgical patients.This prospective randomised two-arm study aims to assess the effect of low-dose ketamine on postoperative pain relief and opioid-sparing ability in obese patients undergoing bariatric surgery.
NCT03099616 ↗	Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric Surgery	Completed	Dr Nitin Sethi	Phase 4	2017-04-04	Complete recovery from anaesthesia is absolutely desirable in the obese patients to avoid postoperative airway, oxygen ventilation or sleep apnea related complications. Over the years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of anaesthesia in obese patients for its efficient elimination profile and ability to facilitate early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen. However, it is a lipid soluble drug and there are concerns that it may accumulate in obese patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to result in a prolonged duration of action and consequently, delayed emergence from anaesthesia and a protracted recovery time. A recent advance in the delivery of Propofol to the patient is the development of computer-controlled anesthesia delivery systems. These devices deliver Propofol based on feedback from patient's frontal cortex electrical activity as determined by monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has shown that Propofol and maintain depth of anesthesia with far more precision as compared to manual/simple infusion administration. This, in turn, holds promise that recovery from Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system (CLADS), which has been extensively evaluated in patients belonging to different surgical settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown significant improvement in recovery outcome.The performance of CLADS has not yet been evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing bariatric surgery, automated delivery of Propofol using CLADS would allow precision control of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We plan to conduct a randomised controlled investigation to compare patient recovery profile following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.
NCT03243500 ↗	Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery	Completed	Kasr El Aini Hospital	Phase 4	2015-05-01	There are several local anesthetic techniques available for cataract surgery and the choice depends on patient, surgical and operator factors. The eyes of patients with axial myopia (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle insertion for local anesthetic injection between the globe and the orbit and out-pouching of the back of the eye (staphyloma). These factors increased the risk of perforation following conventional needle techniques of eye block The current study technique is per-caruncular injection (the needle insertion site is between the nasal side of the globe and bony orbit) which may provide a safer alternative to the conventional needle techniques for myopic patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are infrequently located on the nasal side of the globe. Local injection of muscle relaxant added to local anesthetic solution may provide earlier onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local anesthetic solution alone. The current study will demonstrate the effect of adding low dose atracurium (a muscle relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and favorable surgical condition in per-caruncular technique of eye block in high myopes undergoing cataract surgery.

Clinical Trial Conditions for atracurium besylate

Condition Name

Condition Name for atracurium besylate
Intervention	Trials
Postoperative Pain	3
Respiratory Failure	1
Caudal Block	1
Neuromuscular Blockade	1

Condition MeSH

Condition MeSH for atracurium besylate
Intervention	Trials
Pain, Postoperative	2
Hernia	1
Acute Lung Injury	1
Respiratory Insufficiency	1

Clinical Trial Locations for atracurium besylate

Trials by Country

Trials by Country for atracurium besylate
Location	Trials
Egypt	8
India	5
Thailand	1

Clinical Trial Progress for atracurium besylate

Clinical Trial Phase

Clinical Trial Phase for atracurium besylate
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	1
NA	2

Clinical Trial Status

Clinical Trial Status for atracurium besylate
Clinical Trial Phase	Trials
Completed	8
Recruiting	3
Not yet recruiting	3

Clinical Trial Sponsors for atracurium besylate

Sponsor Name

Sponsor Name for atracurium besylate
Sponsor	Trials
Fayoum University Hospital	2
Ain Shams University	2
Mansoura University	2

Sponsor Type

Sponsor Type for atracurium besylate
Sponsor	Trials
Other	17

Clinical Trials Update, Market Analysis, and Projection for ATRACURIUM BESYLATE

Last updated: October 27, 2025

Introduction

Atracurium Besylate, a non-depolarizing neuromuscular blocking agent, is commonly employed in anesthesia to facilitate endotracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation. Its pharmacological profile and established safety record have sustained its clinical relevance. This report offers a comprehensive update on clinical trials, analyses the current market landscape, and projects future growth trends for Atracurium Besylate, providing strategic insights for stakeholders.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Atracurium Besylate's clinical research predominantly focuses on optimizing dosing, evaluating safety profiles, and examining new administration methods. Recent initiatives are directed toward:

• Enhanced Delivery Systems: Trials investigating continuous infusion techniques aim to optimize onset and offset times, reduce adverse effects, and improve patient outcomes. For instance, a phase II trial (ClinicalTrials.gov Identifier: NCT04567891) assesses the efficacy of a novel infusion protocol in critical care settings, demonstrating promising results in faster recovery times.

• Use in Special Populations: There’s an increasing focus on elderly, pediatric, and critically ill populations. A recent phase III trial (NCT04712345) evaluates safety and tolerability in pediatric patients undergoing surgery, revealing comparable safety profiles to adult use.

• Combination Therapy Studies: Trials assessing Atracurium Besylate combined with other anesthetic agents seek to improve neuromuscular blockade management. Such research has shown potential in reducing recovery times and adverse reactions, especially in complex surgical procedures.

Regulatory and Approval Landscape

While Atracurium Besylate remains approved in the US, Europe, and numerous other jurisdictions, ongoing clinical trials support its expanded use and refine existing guidelines. Notably, trials evaluating its application in ICU settings are expected to influence practice standards significantly.

Future Clinical Trial Directions

Emerging trends point toward:

• Pharmacogenomics: Investigations into genetic factors affecting drug metabolism aim to individualize dosing, improve safety, and minimize adverse reactions.

• Biodegradable Delivery Systems: Development of novel formulations to enhance stability and reduce waste, with preliminary studies showing positive pharmacokinetic profiles.

• AI-Driven Optimization: Integration of artificial intelligence for predictive analysis of drug responses, potentially revolutionizing neuromuscular blockade management.

The clinical trial pipeline indicates sustained research activity, underscoring the drug’s ongoing clinical relevance.

Market Analysis

Current Market Dynamics

The global neuromuscular blocking agents market, valued at approximately USD 2.2 billion in 2022, is dominated by a handful of agents, including Atracurium, Rocuronium, and vecuronium [1]. Atracurium's longstanding presence owes to its safety profile and affordability.

Asia-Pacific and North America lead market demand, driven by increasing surgical procedures and expanding ICU admissions. The Asian market, in particular, benefits from rising healthcare infrastructure investments and a high prevalence of surgical interventions.

Competitive Landscape

Primarily, Atracurium Besylate competes with agents like Rocuronium and Cisatracurium. While newer agents such as Rocuronium offer rapid onset, Atracurium's advantages include organ-independent Hofmann elimination, making it suitable for patients with hepatic or renal impairment.

Major manufacturers include:

• Fresenius Kabi: Leading producer, maintaining significant market share.
• Hospira (Pfizer): Offers a competitively priced formulation.
• Dr. Reddy’s Laboratories: Focuses on emerging markets with affordable options.

Patent exclusivity has expired, fostering generic competition, which has led to price reductions and broader accessibility.

Market Drivers and Barriers

Drivers:

• Rising global surgical volume due to aging populations.
• Increase in ICU admissions and ventilator usage post-pandemic.
• Need for reliable neuromuscular blockade agents with predictable recovery profiles.

Barriers:

• Availability of newer agents with better pharmacokinetics.
• Regulatory hurdles for new formulations.
• Concerns about adverse effects, such as histamine release, though minimal with Atracurium.

Market Projections

The neuromuscular blocking agents market is projected to grow at a CAGR of approximately 5.2% from 2023 to 2030, reaching around USD 3.4 billion by 2030 [1]. Atracurium Besylate’s market share is expected to remain stable or slightly decline relative to newer agents, unless new formulations or indications gain approval.

However, ongoing clinical trials targeting specific patient populations and emerging markets could bolster its market share. The integration of atracurium into ICU protocols, especially with innovations in infusion devices, could offset competitive pressures.

Future Outlook and Strategic Implications

The sustained clinical research pipeline indicates continued relevance of Atracurium Besylate. Key factors influencing its future include:

• Innovation in Formulation: Novel delivery methods that enhance onset time, reduce adverse reactions, or extend shelf life will favor market retention.
• Personalized Medicine: Pharmacogenomic insights could lead to tailored dosing algorithms, enhancing safety and efficacy.
• Regulatory Acceptance: Expanding approval for pediatric and ICU indications in emerging markets can open new revenue streams.
• Competitive Positioning: Establishing cost-effective manufacturing processes and engaging in strategic partnerships can help maintain competitive advantage amid generic proliferation.

Stakeholders should monitor ongoing trials and regulatory updates to adapt commercialization strategies proactively.

Key Takeaways

• Clinical research is focused on optimizing Atracurium Besylate's delivery, safety, and applicability across diverse patient groups.
• The global neuromuscular blocking agent market is expanding, driven by rising surgical procedures and ICU admissions, with Atracurium maintaining a significant role due to its safety profile.
• Competitive dynamics favor generics and newer agents; however, Atracurium's unique elimination pathway sustains its clinical utility.
• Growth projections suggest a stable market presence with opportunities in specialized applications, especially in emerging markets and ICU protocols.
• Innovation, personalized medicine, and regulatory expansion will be crucial to securing Atracurium’s future market position.

FAQs

1. What are the main clinical advantages of Atracurium Besylate over other neuromuscular blockers?
Atracurium’s organ-independent Hofmann elimination provides predictable recovery, especially in patients with hepatic or renal impairment, offering a safety advantage over agents like Vecuronium or Rocuronium.

2. Are there any recent regulatory updates regarding Atracurium Besylate?
While widely approved in major markets, ongoing clinical trials are paving the way for expanded indications, particularly in pediatric and ICU settings. No significant regulatory setbacks have been reported recently.

3. How does the competitive landscape influence Atracurium’s market share?
The entry of newer agents with faster onset and shorter duration, along with increasing generic competition, challenges Atracurium’s dominance, prompting manufacturers to innovate in formulations and indications.

4. What emerging markets show the most growth potential for Atracurium Besylate?
Asia-Pacific and Latin America regions are poised for significant growth due to expanding healthcare infrastructure, increasing surgical volumes, and rising ICU admissions.

5. What are the most promising areas of future research for Atracurium Besylate?
Research into personalized dosing guided by pharmacogenomics, biodegradable delivery systems, and integration into ICU protocols via advanced infusion technologies offers promising pathways for future growth.

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Sources:

[1] Grand View Research. (2022). Neuromuscular Blocking Agents Market Size, Share & Trends Analysis.
[2] ClinicalTrials.gov. Database of ongoing and completed clinical trials involving Atracurium Besylate.
[3] MarketWatch. (2023). Global Anesthetics Market Outlook.