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.

Clinical Trial Conditions for Atracurium Besylate

Condition Name

Condition Name for Atracurium Besylate
Intervention	Trials
Postoperative Pain	3
Patient With Nasolacrimal Duct Obstruction	1
Distal Hypospadias	1

Condition MeSH

Condition MeSH for Atracurium Besylate
Intervention	Trials
Pain, Postoperative	2
Critical Illness	1
Fistula	1

Clinical Trial Locations for Atracurium Besylate

Trials by Country

Trials by Country for Atracurium Besylate
Location	Trials
Egypt	6
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
N/A	6

Clinical Trial Status

Clinical Trial Status for Atracurium Besylate
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	3
Unknown status	2

Clinical Trial Sponsors for Atracurium Besylate

Sponsor Name

Sponsor Name for Atracurium Besylate
Sponsor	Trials
Dr Nitin Sethi	2
Mansoura University	2
Sir Ganga Ram Hospital	2

Sponsor Type

Sponsor Type for Atracurium Besylate
Sponsor	Trials
Other	15

Atracurium Besylate: Clinical Trials, Market Analysis, and Projections

Introduction

Atracurium besylate is a nondepolarizing skeletal muscle relaxant widely used in surgical and critical care settings to facilitate endotracheal intubation and maintain muscle relaxation during surgeries and mechanical ventilation. Here, we delve into the clinical trials, market analysis, and projections for this crucial medication.

Clinical Trials and Safety Profile

Efficacy and Safety

Clinical trials have demonstrated that atracurium besylate is well-tolerated and effective in achieving neuromuscular block. In studies involving 875 patients, atracurium besylate produced few adverse reactions, with most being suggestive of histamine release, such as skin flush, erythema, and itching. The overall incidence rate for clinically important adverse reactions was approximately 0.8%[4].

Histamine Release and Hemodynamic Changes

Atracurium besylate is known to be a less potent histamine releaser compared to other nondepolarizing agents like d-tubocurarine or metocurine. However, doses above 0.6 mg/kg can lead to moderate histamine release and significant falls in blood pressure, particularly in patients with significant cardiovascular disease[1][3][4].

Long-Term Use in ICU

Studies on the long-term infusion of atracurium besylate in ICU settings have shown that average infusion rates of 11 to 13 mcg/kg per minute are required to maintain adequate neuromuscular block. The recovery times after discontinuation of the infusion were generally within 30 to 75 minutes for spontaneous recovery of four twitches in a train-of-four, and 60 minutes for a train-of-four ratio >75%[1][3].

Market Analysis

Market Growth Drivers

The atracurium besylate market is driven by several key factors:

• Increasing Surgical Procedures: The rise in the number of surgeries, particularly advanced surgeries that require prolonged muscle relaxation, has increased the demand for atracurium besylate[2][5].
• Advancements in Critical Care: The growing need for mechanical ventilation in critical care settings further boosts the demand for this medication[2][5].
• Expanding Healthcare Expenditure: Increased healthcare expenditure and improved access to medical facilities in emerging markets such as Asia-Pacific, Latin America, and Africa are driving the adoption of atracurium besylate[5].

Market Trends

Several trends are shaping the atracurium besylate market:

• Innovations in Drug Delivery Systems: Technological advancements have led to the development of pre-filled syringes and ready-to-use formulations, enhancing drug administration efficiency and reducing wastage[5].
• Expansion into Emerging Markets: The market is expanding into regions with rising healthcare expenditure and improved access to medical facilities[5].
• Collaborations and Strategic Partnerships: Partnerships between pharmaceutical companies and healthcare organizations are improving supply chain efficiency and ensuring widespread availability of the drug[5].
• Regulatory Approvals and R&D Focus: Increased focus on research and development has resulted in the approval of new formulations, ensuring compliance with international standards and improving drug efficacy[5].

Market Challenges

Despite the growth, the market faces several challenges:

• High Manufacturing Costs: The production of atracurium besylate is costly, which can impact its affordability and availability.
• Stringent Regulatory Requirements: Compliance with regulatory standards can be challenging and time-consuming.
• Limited Awareness: In some regions, there may be limited awareness about the benefits and proper use of atracurium besylate.
• Competition from Alternative Drugs: The market competes with other neuromuscular blocking agents, which can affect its market share[5].

Market Projections

Growth Potential

The atracurium besylate market is anticipated to attain substantial growth by the end of the forecast period. This growth is driven by the increasing demand for surgical and critical care services, advancements in medical technology, and the expanding healthcare expenditure globally[2][5].

Investment Opportunities

The market presents lucrative opportunities for investors due to its critical role in healthcare, rising demand, and ongoing innovations. The predictable elimination process of atracurium besylate, which reduces the risk of prolonged paralysis, enhances patient safety and recovery outcomes, making it an attractive investment option[5].

Key Takeaways

• Atracurium besylate is a well-tolerated and effective nondepolarizing neuromuscular blocking agent.
• Clinical trials have shown minimal adverse reactions, primarily related to histamine release.
• The market is driven by increasing surgical procedures, advancements in critical care, and expanding healthcare expenditure.
• Innovations in drug delivery systems, expansion into emerging markets, and strategic partnerships are key trends.
• Despite challenges, the market is poised for substantial growth, offering significant investment opportunities.

FAQs

1. What is the primary use of atracurium besylate?

Atracurium besylate is used as a neuromuscular blocking agent to relax skeletal muscles during surgeries and facilitate mechanical ventilation in critical care settings[5].

2. Why is the atracurium besylate market growing?

The market is growing due to increasing surgical procedures, advancements in critical care, and rising healthcare expenditure worldwide[2][5].

3. What are the key trends in the atracurium besylate market?

Key trends include innovations in drug delivery systems, expansion into emerging markets, strategic collaborations, and advancements in R&D[5].

4. What challenges does the atracurium besylate market face?

Challenges include high manufacturing costs, stringent regulatory requirements, limited awareness, and competition from alternative drugs[5].

5. Is investing in the atracurium besylate market beneficial?

Yes, the market presents significant investment opportunities due to its critical role in healthcare, rising demand, and ongoing innovations in the field[5].

Sources

1. Drugs.com: Atracurium Besylate Injection: Package Insert / Prescribing Info
2. FutureWiseResearch: Global Atracurium Besylate Market
3. Pfizer Medical Information: Atracurium Besylate Injection USP
4. Pfizer Medical Information: Atracurium Besylate Injection, USP Adverse Reactions
5. MarketResearchIntellect: Atracurium Besylate Market Size And Projection