CLINICAL TRIALS PROFILE FOR ISOFLURANE

505(b)(2) Clinical Trials for isoflurane

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT05708742 ↗	Erector Spinae Plane Block and Ankle and Foot Surgery	Recruiting	Fayoum University Hospital	N/A	2023-01-01	Regional anesthesia is commonly used in orthopedic and surgical procedures in ankle and foot surgery to manage pain. The ultrasound-guided nerve block is a safe and effective regional anesthesia technique that provides effective pain management, decreasing opioid consumption. Postoperative pain management may be challenging and requires a multimodal approach. Regional anesthesia techniques in the pediatric ankle and foot surgery population are frequently used in postoperative pain management due to ultrasonography's increased experience and accessibility. Erector spinae plane block (ESP) is a relatively new regional anesthesia technique that provides analgesia covering spinal nerves' dorsal and ventral rami. There are few cases reports in the literature on the use of ESP block for lower limb surgery, for which it has a promising potential for future indication. The erector spinae plane block is a safe and effective regional anesthesia technique, which has earned new indications perioperatively since its description.
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for isoflurane

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000259 ↗	Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11	Completed	National Institute on Drug Abuse (NIDA)	N/A	1996-08-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.
NCT00000259 ↗	Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11	Completed	University of Chicago	N/A	1996-08-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.
NCT00000254 ↗	Isoflurane at Subanesthetic Concentrations - 6	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-01-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.
NCT00000254 ↗	Isoflurane at Subanesthetic Concentrations - 6	Completed	University of Chicago	Phase 2	1995-01-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.
NCT00000251 ↗	Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-04-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
NCT00000251 ↗	Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3	Completed	University of Chicago	Phase 2	1994-04-01	The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.

Clinical Trial Conditions for isoflurane

Condition Name

Condition Name for isoflurane
Intervention	Trials
Anesthesia	17
Postoperative Pain	13
Pain, Postoperative	11
Dexmedetomidine	6

Condition MeSH

Condition MeSH for isoflurane
Intervention	Trials
Pain, Postoperative	30
Hypotension	9
Heart Diseases	9
Delirium	8

Clinical Trial Locations for isoflurane

Trials by Country

+

−

Trials by Country for isoflurane
Location	Trials
Egypt	70
China	41
United States	33
Brazil	10
Canada	9

Trials by US State

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−

Trials by US State for isoflurane
Location	Trials
New York	4
Ohio	4
Texas	4
North Carolina	4
Illinois	3

Clinical Trial Progress for isoflurane

Clinical Trial Phase

Clinical Trial Phase for isoflurane
Clinical Trial Phase	Trials
Phase 4	80
Phase 3	21
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for isoflurane
Clinical Trial Phase	Trials
Completed	118
Recruiting	50
Unknown status	28

Clinical Trial Sponsors for isoflurane

Sponsor Name

Sponsor Name for isoflurane
Sponsor	Trials
Kasr El Aini Hospital	12
Fayoum University Hospital	12
Ain Shams University	10

Sponsor Type

Sponsor Type for isoflurane
Sponsor	Trials
Other	313
Industry	6
NIH	5

Isoflurane: Clinical Trials, Market Analysis, and Projections

Introduction to Isoflurane

Isoflurane is a widely used inhalational anesthetic agent known for its efficacy and safety profile in various medical settings. Here, we will delve into the latest clinical trials, market analysis, and projections for isoflurane.

Clinical Trials Update

Efficacy and Safety Comparison with Propofol

A significant phase 3, randomized, controlled, open-label non-inferiority trial compared the efficacy and safety of isoflurane with propofol for sedation in mechanically ventilated ICU patients. This study, conducted in Germany and Slovenia, involved 338 patients and found that isoflurane was non-inferior to propofol in maintaining the target sedation level. Key findings included a lower opioid dose intensity with isoflurane, more frequent spontaneous breathing, and faster wake-up times after isoflurane sedation[1].

Ongoing and Planned Studies

Another ongoing phase 3 study, known as the INSPiRE-ICU1 trial, is comparing the safety and efficacy of inhaled isoflurane delivered via the Sedaconda ACD-S device system with intravenous propofol for sedation in ICU patients. This multicenter, randomized, controlled study aims to assess various endpoints including sedation levels, opioid requirements, and adverse events[3][5].

Market Analysis

Global Market Size and Growth

The global isoflurane market is projected to grow at a compound annual growth rate (CAGR) of 4.60% from 2024 to 2031. As of 2024, the market size is estimated to be in the millions of USD, with North America holding over 40% of the global revenue, followed by Europe with more than 30%, and the Asia Pacific region with around 23%[2].

Segment Analysis

The isoflurane market is segmented based on formulation, type, application, and other factors. The dominating category is anesthesia, driven by the increasing number of surgical procedures globally. Hospitals are the primary centers for isoflurane use, but other medical institutions such as specialty clinics and ambulatory surgical centers are also witnessing significant growth due to the trend towards outpatient surgeries and minimally invasive procedures[2].

Veterinary Medicine Segment

The fastest-growing category in the isoflurane market is veterinary medicine. This growth is fueled by the increasing trend of pet ownership, higher spending on pet healthcare, advancements in animal diagnostics and treatments, and rising awareness of animal welfare[2].

Market Projections

Regional Growth

• North America: Expected to grow at a CAGR of 2.8% from 2024 to 2031, driven by the expanding healthcare infrastructure and increasing surgical procedures.
• Europe: Projected to grow at a CAGR of 3.1% during the same period, influenced by the high prevalence of chronic diseases and advanced healthcare facilities.
• Asia Pacific: Anticipated to grow at a CAGR of 6.6%, driven by the rapid expansion of healthcare services and increasing demand for surgical procedures.
• Latin America and Middle East & Africa: Expected to grow at CAGRs of 4.0% and 4.3%, respectively, due to improving healthcare infrastructure and rising healthcare spending[2].

Factors Influencing Growth

The growth of the isoflurane market is influenced by several key factors:

• Increasing Surgical Procedures: The rising number of surgeries globally, including those in the geriatric population, drives the demand for isoflurane.
• Advancements in Healthcare: Improvements in healthcare infrastructure, medical technology, and anesthesia delivery systems contribute to the market growth.
• Safety Profile: Isoflurane's favorable safety profile, including minimal risk of fulminant hepatitis and faster recovery compared to other anesthetics, enhances its adoption[2][4].

Key Takeaways

• Clinical Efficacy: Isoflurane has been shown to be non-inferior to propofol in maintaining target sedation levels and offers benefits such as lower opioid requirements and faster wake-up times.
• Market Growth: The global isoflurane market is projected to grow at a CAGR of 4.60% from 2024 to 2031, driven by increasing surgical procedures and advancements in healthcare.
• Regional Trends: North America, Europe, and the Asia Pacific region are expected to be significant contributors to the market growth.
• Segmental Growth: The anesthesia segment, particularly in hospitals and other medical institutions, and the veterinary medicine segment are expected to drive market expansion.

FAQs

What is the current status of clinical trials comparing isoflurane with propofol?

Clinical trials, such as the INSPiRE-ICU1 study, are ongoing to compare the safety and efficacy of inhaled isoflurane with intravenous propofol for sedation in ICU patients.

What is the projected growth rate of the global isoflurane market?

The global isoflurane market is expected to grow at a CAGR of 4.60% from 2024 to 2031.

Which regions are expected to contribute significantly to the isoflurane market growth?

North America, Europe, and the Asia Pacific region are anticipated to be major contributors to the market growth.

What are the key factors driving the growth of the isoflurane market?

The growth is driven by increasing surgical procedures, advancements in healthcare infrastructure and technology, and the favorable safety profile of isoflurane.

Which segment is expected to be the fastest-growing in the isoflurane market?

The veterinary medicine segment is expected to be the fastest-growing, driven by increasing pet ownership and spending on pet healthcare.

What are the primary applications of isoflurane?

Isoflurane is primarily used as an inhalational anesthetic agent in hospitals and other medical institutions, as well as in veterinary medicine.

Sources

1. PubMed: "Inhaled isoflurane via the anaesthetic conserving device ... - PubMed"
2. Cognitive Market Research: "Isoflurane market Will Grow at a CAGR of 4.60% from 2024 to 2031."
3. CenterWatch: "Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)"
4. Global Market Insights: "Inhalation Anesthesia Market 2019-2025 | Global Industry Share"
5. UCSD Clinical Trials: "Sedation clinical trials at UCSD"