CLINICAL TRIALS PROFILE FOR PROPOFOL

505(b)(2) Clinical Trials for PROPOFOL

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 Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Baylor College of Medicine	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children's Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children’s Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
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 PROPOFOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00095251 ↗	MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status	Completed	Vanderbilt University	Phase 2	2004-08-01	Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
NCT00095251 ↗	MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status	Completed	Vanderbilt University Medical Center	Phase 2	2004-08-01	Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Clinical Trial Conditions for PROPOFOL

Condition Name

Condition Name for PROPOFOL
Intervention	Trials
Anesthesia	185
Postoperative Pain	74
Pain	65
Pain, Postoperative	59

Condition MeSH

Condition MeSH for PROPOFOL
Intervention	Trials
Pain, Postoperative	157
Delirium	75
Postoperative Nausea and Vomiting	41
Vomiting	40

Clinical Trial Locations for PROPOFOL

Trials by Country

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−

Trials by Country for PROPOFOL
Location	Trials
United States	463
China	289
Egypt	188
Korea, Republic of	164
France	85

Trials by US State

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−

Trials by US State for PROPOFOL
Location	Trials
New York	41
Texas	35
California	34
Ohio	29
Illinois	26

Clinical Trial Progress for PROPOFOL

Clinical Trial Phase

Clinical Trial Phase for PROPOFOL
Clinical Trial Phase	Trials
Phase 4	722
Phase 3	183
Phase 2/Phase 3	54

Clinical Trial Status

Clinical Trial Status for PROPOFOL
Clinical Trial Phase	Trials
Completed	1010
Recruiting	286
Unknown status	229

Clinical Trial Sponsors for PROPOFOL

Sponsor Name

Sponsor Name for PROPOFOL
Sponsor	Trials
Yonsei University	57
Assiut University	35
Mansoura University	25

Sponsor Type

Sponsor Type for PROPOFOL
Sponsor	Trials
Other	2352
Industry	178
NIH	19

Propofol: Clinical Trials, Market Analysis, and Projections

Introduction to Propofol

Propofol is a widely used general anesthetic and sedative, known for its rapid onset and short duration of action. It is essential in various medical procedures, including surgeries, intensive care, and diagnostic tests. Here, we will delve into recent clinical trials, market analysis, and projections for propofol.

Clinical Trials Update

Antidepressant Properties of Propofol

A notable clinical trial has explored the antidepressant properties of propofol. In an open-label trial, 10 participants with moderate-to-severe medication-resistant depression received a series of 10 propofol infusions. The results showed that propofol treatments were well tolerated, with no serious adverse events. The Hamilton Depression Rating Scale scores decreased by a mean of 20 points, corresponding to a 58% improvement from baseline. Six of the 10 subjects met the criteria for response (>50% improvement), and five of these responders remained well for at least 3 months. This study suggests that high-dose propofol may trigger rapid and durable antidepressant effects similar to electroconvulsive therapy but with fewer side effects[1].

Ciprofol: A Novel Alternative

Ciprofol, a structural modification of propofol, has been studied as a potential alternative. Clinical trials have evaluated ciprofol's efficacy and safety in various procedures, including gastroscopy, colonoscopy, fiber-optic bronchoscopy, and general anesthesia in elective surgeries. The results indicate that ciprofol has high efficacy, good selectivity, and fewer adverse reactions compared to propofol. Ciprofol has been approved by the China National Medical Products Administration for sedation and anesthesia during nontracheal intubation and intensive care. These studies suggest that ciprofol could be a viable alternative to propofol in clinical settings[4].

Market Analysis

Global Market Size and Growth

The global propofol market is experiencing significant growth driven by several factors. As of 2024, the market size is estimated to be around USD 1.04 billion and is projected to reach USD 2.01 billion by 2037, growing at a compound annual growth rate (CAGR) of 5.2% during the forecast period[5].

Regional Market Breakdown

• North America: This region holds the largest market share, driven by the high number of well-established healthcare facilities, the adoption of minimally invasive surgical procedures, and the easy availability of the drug. The North American market is expected to grow at a CAGR of 9% from 2024 to 2031[2][5].
• Europe: Europe is the second-largest market, with a CAGR of 9.3% from 2024 to 2031. The growth is attributed to advancements in healthcare infrastructure and technology, as well as increasing healthcare expenditure and favorable reimbursement policies[2].
• Asia Pacific: This region is expected to grow at a CAGR of 12.8% from 2024 to 2031, driven by expanding healthcare infrastructure, rising investments in medical services, and an increasing population with chronic diseases[2].
• Middle East and Africa: The MEA region is also seeing growth, with a CAGR of 10.5% from 2024 to 2031, due to improvements in healthcare infrastructure and the growing prevalence of chronic diseases[2].

Market Segmentation

The propofol market is segmented based on application and distribution channels. The general anesthesia segment holds a significant market share due to the rising number of surgical procedures globally. Hospitals are expected to garner the largest market share in terms of distribution channels, owing to the high number of admissions and the availability of appropriate medical equipment[5].

Growth Drivers

• Increasing Surgical Procedures: The global increase in surgical operations, including general surgical, orthodontic, and dental surgical procedures, drives the demand for propofol.
• Advancements in Healthcare Infrastructure: Improvements in surgical techniques and healthcare infrastructure enhance the efficiency and safety of propofol administration.
• Chronic and Age-Related Disorders: The growing incidence of chronic and age-related disorders that require surgical interventions contributes to market growth.
• Research and Development: Continuous R&D initiatives to promote patient safety and better medicine formulations also drive market expansion[3][5].

Market Projections

Future Outlook

The propofol market is expected to continue growing steadily due to several factors:

• Rising Healthcare Facilities: The expansion of healthcare facilities and the increasing adoption of minimally invasive surgical procedures will drive demand.
• Technological Advancements: Improvements in medical technology and anesthesia delivery systems will enhance the safety and efficiency of propofol administration.
• Regulatory Approvals: Regulatory approvals for novel formulations and indications will expand the market reach.
• Affordable Formulations: The pharmaceutical industry's focus on creating affordable formulations and generic equivalents will increase accessibility[3][5].

Statistical Highlights

• Global Market Size 2024: USD 1.04 billion[5].
• Projected Market Size 2037: USD 2.01 billion[5].
• CAGR 2024-2037: 5.2%[5].
• North America Market Size 2024: USD 540.88 million[2].
• Asia Pacific CAGR 2024-2031: 12.8%[2].

Key Takeaways

• Propofol shows promising antidepressant properties in clinical trials.
• Ciprofol, a novel alternative to propofol, demonstrates high efficacy and safety.
• The global propofol market is growing significantly, driven by increasing surgical procedures and advancements in healthcare infrastructure.
• North America and Europe are the leading regions in the propofol market.
• The market is expected to continue growing due to technological advancements, regulatory approvals, and the development of affordable formulations.

FAQs

What are the recent clinical trials indicating about propofol's antidepressant properties?

Recent clinical trials suggest that propofol may have rapid and durable antidepressant effects similar to electroconvulsive therapy but with fewer side effects for individuals with treatment-resistant depression[1].

What is Ciprofol, and how does it compare to propofol?

Ciprofol is a novel compound developed in China, structurally modified from propofol. It has shown high efficacy, good selectivity, and fewer adverse reactions compared to propofol in various clinical trials[4].

What is the current global market size of propofol, and what is its projected growth?

The global propofol market size was estimated at USD 1.04 billion in 2024 and is projected to reach USD 2.01 billion by 2037, growing at a CAGR of 5.2% during the forecast period[5].

Which regions are driving the growth of the propofol market?

North America and Europe are the leading regions, with North America expected to dominate the majority of the revenue share. The Asia Pacific region is also growing rapidly due to expanding healthcare infrastructure and rising investments in medical services[2][5].

What are the key drivers of the propofol market growth?

Key drivers include the increasing number of surgical procedures, advancements in healthcare infrastructure, the growing incidence of chronic and age-related disorders, and continuous R&D initiatives to promote patient safety and better medicine formulations[3][5].

Sources

1. Abstract for Propofol Pilot Study | Psychiatry - University of Utah Health
2. Propofol market Will Grow at a CAGR of 10.80% from 2024 to 2031 - Cognitive Market Research
3. Propofol Market Size and Projections - Market Research Intellect
4. Ciprofol: A Novel Alternative to Propofol in Clinical Intravenous Anesthesia? - Wiley Online Library
5. Propofol Market Size & Share, Growth Outlook 2036 - Research Nester