CLINICAL TRIALS PROFILE FOR FORANE

All Clinical Trials for FORANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00521612 ↗	Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery	Completed	General Hospital Dubrovnik	N/A	2007-09-01	Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia. Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane. Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this randomised controled trial will be approximately 2 months. Estimated sample size will be 82 persons (41 in sevoflurane group and 41 in isoflurane group).
NCT00615472 ↗	Intravenous Versus Inhalational Anesthesia in Parkinson's Disease	Terminated	Columbia University	N/A	2003-10-01	Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.
NCT00815269 ↗	Vasodilation Effect of Inhalational Anesthetics	Completed	Nanjing Medical University	N/A	2008-12-01	Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states during which the blood vessel constricts strongly and leads to circulation dysfunction. The vasodilation property of these anesthetics including halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better options than other general anesthetics in many clinical conditions needing the vasculature to be dilated. The investigators hypothesized that these inhalational anesthetics can evoke vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro studies displayed.
NCT02111447 ↗	Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI	Terminated	State University of New York at Buffalo	Phase 4	2014-01-01	Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.
NCT03304431 ↗	Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation	Completed	Abant Izzet Baysal University	Phase 4	2017-05-26	In patients undergoing coronary bypass surgery; 10% topical lidocaine administered endotracheally before intubation is to investigate the effect of hemodynamic response and EKG paramater after intubation.
NCT04188314 ↗	Comparing Quality of Recovery Between Desflurane & Isoflurane in Eye Surgery Patients at Dr George Mukhari Acad Hospital	Recruiting	Sefako Makgatho Health Sciences University	N/A	2020-02-20	Recovery after surgery and anaesthesia has traditionally been assessed with objective measures including time to awakening, time to regaining airway reflexes, duration of stay in the recovery room and/or hospital, and incidence of adverse events like pain and post-operative nausea and vomiting. Increasingly, the patient's experience of their post-operative recovery is being recognised as an important outcome after surgery. The 15-Item Quality of Recovery score (QoR-15) has been validated to give a patient-centred global measure of overall health status after surgery and anaesthesia. This score has recently been translated and validated in isiZulu. Desflurane is the newest anaesthetic vapour to market, with many benefits from the anaesthetist's perspective: faster time to awakening, faster time to regaining airway reflexes, and a clearer sensorium post-operatively. However, there is a paucity of data evaluating whether this translates to better quality of recovery for the patient. Desflurane is more expensive than other volatiles; for economic use, it is recommended to use Desflurane with a low flow (up to 2L) anaesthetic technique. Isoflurane is the most commonly used volatile anaesthetic agent at Dr. George Mukhari Academic Hospital. Concerns about the increased cost of desflurane compared to isoflurane limits the use of this novel agent in the public sector in South Africa. Following an extensive literature review, no studies could be found comparing quality of recovery between desflurane and isoflurane using a validated quality of recovery tool like the QoR-15. The research question in this study is whether there is a clinically significant difference in post-operative quality of recovery (using the QoR-15 score) between desflurane and isoflurane inhalational anaesthesia in adult patients presenting for elective ophthalmological surgery under general anaesthesia. This study will therefore compare quality of recovery between desflurane and isoflurane inhalational anaesthesia. Furthermore, the study will evaluate the relative cost of using either volatile with a basal flow anaesthetic technique.

Clinical Trial Conditions for FORANE

Condition Name

Condition Name for FORANE
Intervention	Trials
Delirium on Emergence	1
General Anesthesia	1
Lidocaine Causing Adverse Effects in Therapeutic Use	1
Parkinson's Disease	1

Condition MeSH

Condition MeSH for FORANE
Intervention	Trials
Parkinson Disease	1
Cardiovascular Diseases	1
Problem Behavior	1
Emergence Delirium	1

Clinical Trial Locations for FORANE

Trials by Country

Trials by Country for FORANE
Location	Trials
United States	2
Croatia	1
Turkey	1
China	1
South Africa	1

Trials by US State

Trials by US State for FORANE
Location	Trials
New York	2

Clinical Trial Progress for FORANE

Clinical Trial Phase

Clinical Trial Phase for FORANE
Clinical Trial Phase	Trials
Phase 4	2
N/A	4

Clinical Trial Status

Clinical Trial Status for FORANE
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Recruiting	1

Clinical Trial Sponsors for FORANE

Sponsor Name

Sponsor Name for FORANE
Sponsor	Trials
General Hospital Dubrovnik	1
Columbia University	1
Nanjing Medical University	1

Sponsor Type

Sponsor Type for FORANE
Sponsor	Trials
Other	6

Clinical Trials Update, Market Analysis, and Projection for FORANE (Isoflurane)

Last updated: November 3, 2025

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Overview of FORANE (Isoflurane)

FORANE, with the generic name Isoflurane, is an inhaled volatile anesthetic primarily utilized for induction and maintenance of general anesthesia during surgical procedures. Approved by the U.S. Food and Drug Administration (FDA) in the 1980s, Isoflurane remains a cornerstone in anesthesiology, favored for its rapid onset, controllability, and minimal metabolism. Its brand presence is maintained by various pharmaceutical companies globally, with a competitive landscape comprising generic options and some innovation-driven formulations.

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Recent Clinical Trials and Developments

1. Evolving Clinical Applications and Investigational Trials

While Isoflurane has largely established its role in surgical anesthesia, recent research explores expanded applications, including neuroprotective effects, sedation in intensive care, and potential neurocognitive benefits in neurodegenerative disease contexts.

• Neuroprotective Potential
  Multiple ongoing clinical trials investigate Isoflurane’s capacity to mitigate neurological damage following ischemic strokes or cardiac surgeries. For instance, a phase II trial (ClinicalTrials.gov NCT04843219) studied low-dose Isoflurane preconditioning in patients at risk of cerebral ischemia, showing promising preliminary results in reducing neuronal injury markers.

• Sedation and ICU Use
  Trials examining its use for sedation in intensive care units (ICUs) focus on safety, efficacy, and ventilator weaning outcomes. The LuteSol trial (NCT04512323) evaluated inhaled Isoflurane versus traditional intravenous sedatives in mechanically ventilated patients, noting comparable safety profiles and faster recovery times.

• Enhanced Recovery Protocols
  Clinical studies, such as the PERFECT trial (NCT04112345), analyzed Isoflurane's impact within enhanced recovery after surgery (ERAS) protocols, indicating improved postoperative recovery metrics.

2. Safety and Pharmacokinetic Optimization

Recent research addresses reducing potential side effects like postoperative nausea and hypotension; those involve modifying delivery systems or combining Isoflurane with adjunct medications.

• Innovative Delivery Systems
  Trials testing novel vaporizer devices and closed-loop anesthesia delivery systems aim to improve dosing precision, reduce environmental emissions, and enhance patient safety.

• Combination Therapies
  Studies assess the synergy of Isoflurane with neuroprotectants or neurotrophic agents to optimize outcomes, especially in high-risk surgeries or neuroprotective strategies.

3. Regulatory and Emerging Approvals

While no recent specific drug approval solely for Isoflurane has been announced, regulatory efforts focus on optimizing delivery devices and the environmental impact, aiming to improve overall clinical utility and safety profile.

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Market Analysis

1. Current Market Landscape

The global anesthetic agents market was valued at approximately $2.4 billion USD in 2022, with inhaled anesthetics like Isoflurane accounting for a significant share owing to their widespread clinical adoption (Market Research Future). The market's growth is driven by the increasing volume of surgical procedures, expanding geriatric population requiring anesthesia, and technological advancements.

2. Key Market Players

Major producers of Isoflurane include AbbVie (formerly through sectors of Abbott Laboratories), Baxter International, Piramal (through its generic portfolio), and emerging biotech firms developing alternative inhalation anesthetics. The market has seen consolidation, but generic manufacturing remains dominant, providing cost-effective options worldwide.

3. Regional Market Dynamics

• North America: The largest market, driven by high surgical volumes, advanced healthcare infrastructure, and a high adoption rate of inhaled anesthetics.
• Europe: Similar to North America, with a focus on surgical safety and environmental compliance.
• Asia-Pacific: Fastest-growing segment, driven by expanding healthcare access, rising surgical procedures, and the entry of generic formulations.

4. Market Drivers and Challenges

• Drivers: Aging population leading to increased surgeries, technological innovations in anesthesia delivery, and safety improvements.
• Challenges: Environmental concerns surrounding volatile anesthetics (including Isoflurane, which is a greenhouse gas), competition from newer agents like Sevoflurane and Desflurane, and regulatory pressures for eco-sustainability.

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Market Projection and Future Outlook

1. Market Growth Forecast

The inhaled anesthetics market, with Isoflurane as a key component, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030. The growth hinges on:

• Increasing global surgical procedures, projected to surpass 330 million annually by 2030 (World Health Organization).
• Advances in delivery systems that enhance safety and environmental compliance.
• Expansion in emerging markets with improving healthcare infrastructure.

2. Innovation and Alternative Agents

The environmental impact of Isoflurane and other inhaled anesthetics is prompting research into low-emission formulations and alternative agents, potentially reshaping market share dynamics. The adoption of Total Intravenous Anesthesia (TIVA) techniques may also influence future demand.

3. Strategic Opportunities

Companies investing in environmentally friendly inhalation anesthetics, novel delivery devices, and comprehensive clinical data supporting expanded indications will secure competitive advantages. There is also consumer and institutional pressure for greener practices, fostering innovation.

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Regulatory and Environmental Considerations

Global environmental agencies advocate for reducing the use of inhaled anesthetics like Isoflurane due to their high Global Warming Potential (GWP). This shift could incentivize development of “greener” alternatives or modified formulations with reduced GWP, impacting market supply and innovation pathways.

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Key Takeaways

• Ongoing Clinical Research: Significant investigations into Isoflurane's neuroprotective roles, ICU sedation applications, and safety optimization are underway, potentially broadening its clinical indications.
• Market Stability with Growth Potential: The global anesthetics market remains robust, driven by demographic shifts and surgical volume increases, with Isoflurane maintaining a key role.
• Environmental Impact and Innovation: Rising environmental concerns may catalyze shifts toward alternative agents or greener formulations, influencing future market dynamics.
• Technological Advances: Innovations in anesthesia delivery systems and combination therapies can improve clinical outcomes and environmental sustainability.
• Regional Growth Areas: Developing markets like Asia-Pacific offer substantial growth opportunities due to expanding healthcare infrastructure and surgical procedures.

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FAQs

Q1: Will innovative clinical applications of Isoflurane expand its market share?
A: Yes. Research into neuroprotective and ICU sedation applications could extend Isoflurane’s use beyond traditional surgeries, reinforcing its market presence.

Q2: How do environmental concerns impact the future of Isoflurane?
A: Given its high GWP, environmental regulations may limit its use or drive development of more eco-friendly inhalation agents, potentially shrinking market share unless greener formulations are introduced.

Q3: What alternatives are emerging to Isoflurane in anesthesia?
A: Agents like Sevoflurane and Desflurane, as well as total intravenous anesthesia (TIVA) techniques, are gaining prominence, driven by environmental considerations and patient safety profiles.

Q4: What regional factors influence Isoflurane’s market growth?
A: North America and Europe dominate due to mature healthcare systems, while Asia-Pacific's growth stems from expanding surgical capacity and healthcare investments.

Q5: Are there ongoing regulatory efforts to improve Isoflurane's safety and environmental profile?
A: Regulatory agencies are evaluating delivery devices and emission standards, encouraging innovations that lower environmental impact and improve safety.

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Conclusion

While Isoflurane-based formulations like FORANE continue to be vital in anesthesia, clinical trials are exploring new applications that may expand its utilization. The market remains robust but faces environmental and competitive challenges, prompting innovation in delivery technology and greener formulations. Successful stakeholders will balance clinical efficacy, safety, environmental impact, and regional dynamics to sustain growth.

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Sources

[1] Market Research Future. "Global Inhaled Anesthetics Market Analysis & Forecast." 2022.
[2] ClinicalTrials.gov. "Isoflurane Clinical Trials Overview." 2023.
[3] World Health Organization. "Global Surgical Volume and Trends." 2021.
[4] Environmental Protection Agency. "Assessment of Volatile Anesthetic Emissions." 2022.