CLINICAL TRIALS PROFILE FOR ULTANE

All Clinical Trials for ULTANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02419547 ↗	Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia	Completed	Brigham and Women's Hospital	N/A	2014-07-01	This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure. Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations. This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.
NCT02133638 ↗	Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery	Unknown status	Negovsky Reanimatology Research Institute	Phase 4	2014-05-01	The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.
NCT02053766 ↗	Anesthesia in Patients With Mitochondrial Disease	Recruiting	The University of Texas Health Science Center, Houston	N/A	2014-01-10	This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.
NCT01191476 ↗	Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia	Completed	Rundo International Pharmaceutical Research & Development Co.,Ltd.	Phase 4	2010-11-01	This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.
NCT01191476 ↗	Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia	Completed	Abbott	Phase 4	2010-11-01	This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.
NCT01048658 ↗	Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures	Completed	Oregon Health and Science University	Phase 4	2009-09-01	Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.
NCT00665418 ↗	Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients	Terminated	University Hospital, Basel, Switzerland	Phase 4	2008-02-01	To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses after controlled laryngeal stimulation are completely suppressed in subjects when anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20% (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5% (MAC50) to 4.7% (MACEI95)

Clinical Trial Conditions for ULTANE

Condition Name

Condition Name for ULTANE
Intervention	Trials
Anesthesia	3
Phimosis	2
Balanitis	2
Pain, Postoperative	2

Condition MeSH

Condition MeSH for ULTANE
Intervention	Trials
Pain, Postoperative	2
Balanitis	2
Heart Diseases	2
Delirium	2

Clinical Trial Locations for ULTANE

Trials by Country

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Trials by Country for ULTANE
Location	Trials
United States	10
Canada	2
Thailand	1
Russian Federation	1
China	1

Trials by US State

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−

Trials by US State for ULTANE
Location	Trials
Georgia	2
Wisconsin	1
New York	1
California	1
Missouri	1

Clinical Trial Progress for ULTANE

Clinical Trial Phase

Clinical Trial Phase for ULTANE
Clinical Trial Phase	Trials
Phase 4	10
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for ULTANE
Clinical Trial Phase	Trials
Completed	6
Unknown status	3
Recruiting	3

Clinical Trial Sponsors for ULTANE

Sponsor Name

Sponsor Name for ULTANE
Sponsor	Trials
Alberta Children's Hospital	2
Emory University	2
University of Missouri-Columbia	1

Sponsor Type

Sponsor Type for ULTANE
Sponsor	Trials
Other	15
Industry	2
NIH	1

Clinical Trials, Market Analysis, and Projections for ULTANE (Sevoflurane)

Introduction to ULTANE (Sevoflurane)

ULTANE, also known as sevoflurane, is a volatile liquid used for inhalation anesthesia. It is widely used in surgical procedures due to its rapid onset and recovery times.

Clinical Trials and Efficacy

Recovery and Emergence

Clinical trials have shown that ULTANE offers faster recovery times compared to other anesthetic agents. Adult patients administered ULTANE demonstrated shorter times to recovery, including extubation, response to command, and orientation, compared to those who received isoflurane or propofol[1][4].

Safety Considerations

While ULTANE is generally safe, it is contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia or sensitivity to sevoflurane or other halogenated inhalational anesthetics. Malignant hyperthermia is a rare but potentially fatal condition that can be triggered by these agents, especially when used in conjunction with succinylcholine[1].

Adverse Events

Common adverse events reported during clinical trials include bradycardia, tachycardia, agitation, laryngospasm, airway obstruction, and increased cough during induction. During maintenance and emergence, shivering, hypotension, bradycardia, somnolence, agitation, nausea, vomiting, and increased cough were noted[1].

Market Analysis

Global Anesthesia Market

The global anesthesia market, which includes inhalational anesthetics like ULTANE, is part of the broader clinical trials market. This market is expected to grow significantly, driven by the increasing prevalence of chronic diseases and the rise in R&D activities in the biotechnology and pharmaceutical industries. The global clinical trials market is projected to reach around USD 95 billion by 2030, growing at a CAGR of 7.07% from 2022 to 2030[3].

Market Share and Segmentation

The Phase III segment of clinical trials, where ULTANE is often used, accounted for the largest revenue share in 2021, contributing 53.4% of the global market. This is due to the high costs and extensive patient involvement in Phase III trials. The interventional trials market for autoimmune/inflammation, which may also utilize ULTANE, held the largest share with 82.0% in 2021[3].

Projections and Future Outlook

Growth Drivers

The growth of the ULTANE market is driven by several factors, including the increasing demand for surgical procedures, advancements in anesthesia techniques, and the expanding need for effective and safe anesthetic agents. The oncology segment, which is expected to witness the fastest CAGR of 6.3% over the forecast period, may also contribute to the demand for ULTANE in cancer-related surgeries[3].

Competitive Landscape

ULTANE competes with other inhalational anesthetics such as isoflurane and propofol. Its faster recovery times and efficacy make it a preferred choice in many surgical settings. However, the market is highly competitive, and pharmaceutical companies are continually developing new anesthetic agents, which could impact ULTANE's market share in the future.

Regulatory Considerations

Regulatory approvals and compliance are crucial for the continued use and development of ULTANE. The FDA has approved ULTANE for various indications, and ongoing clinical trials ensure that its safety and efficacy are continuously monitored and improved[4].

Key Takeaways

• Faster Recovery Times: ULTANE offers statistically significant shorter recovery times compared to other anesthetic agents.
• Safety Concerns: It is contraindicated in patients with genetic susceptibility to malignant hyperthermia or sensitivity to halogenated anesthetics.
• Market Growth: The global clinical trials market, which includes the anesthesia segment, is expected to grow significantly by 2030.
• Competitive Market: ULTANE competes with other anesthetic agents and must navigate a highly competitive market.
• Regulatory Compliance: Continuous regulatory monitoring and compliance are essential for ULTANE's continued use.

FAQs

What are the key benefits of using ULTANE in surgical procedures?

ULTANE offers faster recovery times, including extubation, response to command, and orientation, compared to other anesthetic agents like isoflurane and propofol[1][4].

What are the contraindications for using ULTANE?

ULTANE is contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia or sensitivity to sevoflurane or other halogenated inhalational anesthetics[1].

How does ULTANE compare to other anesthetic agents in terms of recovery times?

ULTANE has been shown to have shorter recovery times compared to isoflurane and propofol in clinical trials[1][4].

What is the projected growth of the global clinical trials market, and how does it impact ULTANE?

The global clinical trials market is expected to reach around USD 95 billion by 2030, growing at a CAGR of 7.07% from 2022 to 2030. This growth is driven by increasing R&D activities and the prevalence of chronic diseases, which can increase the demand for effective anesthetic agents like ULTANE[3].

What are the common adverse events associated with ULTANE?

Common adverse events include bradycardia, tachycardia, agitation, laryngospasm, airway obstruction, and increased cough during induction, and shivering, hypotension, bradycardia, somnolence, agitation, nausea, vomiting, and increased cough during maintenance and emergence[1].

Sources

1. Anesthesiology Hub: Recovery & Emergence from Anesthesia - ULTANE® (sevoflurane)
2. FDA: ULTANE® (sevoflurane) volatile liquid for inhalation
3. BioSpace: Clinical Trials Market is Rising Rapidly Up to USD 95 BN by 2030
4. FDA: ULTANE® (sevoflurane) volatile liquid for inhalation (Label)