CLINICAL TRIALS PROFILE FOR NIMBEX

All Clinical Trials for Nimbex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00912990 ↗	Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet	Terminated	Rady Children's Hospital, San Diego	N/A	2007-01-01	The investigators' primary specific aims are to demonstrate that: 1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet. 2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in: - Time to intubation (defined as no more than a 30 second time difference between the two groups); - Incidence of adverse events.
NCT01573715 ↗	Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)	Unknown status	Assistance Publique Hopitaux De Marseille	Phase 4	2012-04-01	Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows: - reduction of the consumption of oxygen linked to ventilatory workload; - increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy; - anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation, - reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator. The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.
NCT01690338 ↗	A Study of Residual Curarization Incidence in China	Unknown status	Central South University	Phase 4	2012-10-01	The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
NCT01690338 ↗	A Study of Residual Curarization Incidence in China	Unknown status	China Medical University Hospital	Phase 4	2012-10-01	The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.

Clinical Trial Conditions for Nimbex

Condition Name

Condition Name for Nimbex
Intervention	Trials
Neuromuscular Blockade	3
Acute Respiratory Distress Syndrome	2
Intubation	1
Respiratory Distress Syndrome, Adult	1

Condition MeSH

Condition MeSH for Nimbex
Intervention	Trials
Respiratory Distress Syndrome, Newborn	3
Respiratory Distress Syndrome, Adult	3
Respiratory Distress Syndrome	3
Acute Lung Injury	3

Clinical Trial Locations for Nimbex

Trials by Country

Trials by Country for Nimbex
Location	Trials
United States	20
China	12
Egypt	2
Czechia	1
Thailand	1

Trials by US State

Trials by US State for Nimbex
Location	Trials
California	2
Illinois	1
Washington	1
Virginia	1
Utah	1

Clinical Trial Progress for Nimbex

Clinical Trial Phase

Clinical Trial Phase for Nimbex
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Nimbex
Clinical Trial Phase	Trials
Completed	8
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for Nimbex

Sponsor Name

Sponsor Name for Nimbex
Sponsor	Trials
Assiut University	2
Zhujiang Hospital	1
Central South University	1

Sponsor Type

Sponsor Type for Nimbex
Sponsor	Trials
Other	36
NIH	1

NIMBEX (Cisatracurium): Clinical Trials, Market Analysis, and Projections

Introduction

NIMBEX, also known as cisatracurium, is a non-depolarizing neuromuscular blocking agent (NMBA) widely used in critical care and surgical settings. This article will delve into the current clinical trials, market analysis, and future projections for NIMBEX, highlighting its role in medical practice and its economic impact.

Clinical Trials and Efficacy

Use in Acute Respiratory Distress Syndrome (ARDS)

Cisatracurium has been extensively studied for its use in patients with ARDS. Several randomized controlled trials have shown that cisatracurium can improve oxygenation and reduce the inflammatory response in these patients. The ACURASYS trial, for instance, found that patients treated with fixed-dose cisatracurium had more ventilator-free days and a significant reduction in barotrauma compared to the placebo group[1].

Monitoring and Dosing Strategies

Clinical trials have also explored different dosing strategies for cisatracurium. The Train-of-Four (TOF) test is commonly used to monitor and adjust the doses of cisatracurium to ensure optimal neuromuscular blockade without causing undue muscle weakness. However, some trials have indicated that fixed-dose strategies may lead to higher cisatracurium consumption and potentially more adverse effects compared to TOF-based titration[1].

Comparative Studies

Studies comparing cisatracurium with other NMBAs, such as rocuronium, have shown that cisatracurium can provide effective neuromuscular blockade with a favorable safety profile. For example, a study on patients with severe renal impairment found that rocuronium followed by reversal with sugammadex was superior to cisatracurium and neostigmine in terms of faster recovery of neuromuscular function[4].

Market Analysis

Current Market

The market for NMBAs, including cisatracurium, is part of the broader anesthesiology and critical care market. While specific sales figures for NIMBEX are not readily available, the overall market for anesthetic agents is significant. The U.S. clinical trials market, which includes studies on anesthetic agents, was valued at $25.81 billion in 2023 and is expected to grow to $41.57 billion by 2033[3].

Competitive Landscape

Cisatracurium competes with other NMBAs such as rocuronium, vecuronium, and succinylcholine. The choice of NMBA often depends on the specific clinical scenario, patient characteristics, and the preferences of the anesthesiologist or intensivist. Cisatracurium's unique profile, including its lack of histamine release and its anti-inflammatory properties, makes it a preferred choice in certain critical care settings[1].

Market Projections

Growth Drivers

The demand for NMBAs like cisatracurium is driven by several factors, including the increasing number of surgical procedures and the growing need for critical care services. The rise in complex surgeries and the aging population contribute to the growth of the NMBA market.

Economic Impact

While the NSCLC market, which is unrelated to NMBAs, is projected to grow significantly due to the adoption of immunotherapies and targeted therapies, the anesthesiology market, including NMBAs, is expected to see steady growth. The increasing complexity of surgical procedures and the need for advanced anesthetic agents will drive the market for NMBAs like cisatracurium[2].

Regulatory and Safety Considerations

FDA Oversight

Clinical trials involving NMBAs, including cisatracurium, are rigorously regulated by the FDA to ensure patient safety and data integrity. Adverse event reports and post-marketing surveillance are crucial in maintaining the safety profile of these drugs[3].

Safety Profile

Cisatracurium has a favorable safety profile compared to other NMBAs. It does not cause significant histamine release, which reduces the risk of anaphylactic reactions. However, as with all NMBAs, there is a risk of ICU-acquired weakness, which must be monitored and managed appropriately[1].

Key Takeaways

• Clinical Efficacy: Cisatracurium has been shown to improve outcomes in patients with ARDS, particularly in terms of oxygenation and reduction of barotrauma.
• Dosing Strategies: Fixed-dose and TOF-based titration strategies have been compared, with TOF-based titration often recommended for optimal neuromuscular blockade.
• Market Growth: The market for NMBAs is expected to grow steadily, driven by increasing surgical procedures and critical care needs.
• Safety Profile: Cisatracurium has a favorable safety profile, but monitoring for adverse effects such as ICU-acquired weakness is essential.

FAQs

What is the primary use of cisatracurium in critical care?

Cisatracurium is primarily used in critical care to facilitate mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) and to manage neuromuscular blockade during surgical procedures.

How does cisatracurium compare to other NMBAs?

Cisatracurium is unique due to its lack of histamine release and its potential anti-inflammatory benefits. It is often preferred in critical care settings where these properties are advantageous.

What are the key findings from clinical trials on cisatracurium in ARDS?

Clinical trials have shown that cisatracurium can improve oxygenation, reduce the inflammatory response, and decrease the risk of barotrauma in patients with ARDS.

How is the dosing of cisatracurium typically managed?

The dosing of cisatracurium is often managed using the Train-of-Four (TOF) test to ensure optimal neuromuscular blockade and to adjust doses as necessary.

What are the potential adverse effects of cisatracurium?

While cisatracurium has a favorable safety profile, potential adverse effects include ICU-acquired weakness and, in some cases, increased cardiovascular adverse events when used in fixed-dose strategies.

Sources

1. University of Illinois at Chicago, College of Pharmacy: "Are there data available to support use of fixed-dose cisatracurium for acute respiratory distress syndrome (ARDS)?"[1]
2. GlobalData: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025"[2]
3. Biospace: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033"[3]
4. Unbound Medicine: "Nimbex journal articles from PubMed"[4]