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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR SEVOFLURANE

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505(b)(2) Clinical Trials for Sevoflurane

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
OTC NCT01691690 Analgesic Effect of IV Acetaminophen in Tonsillectomies Active, not recruiting 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 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).
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 surgery lasting at least 2..5 hours. 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 Children's Hospital of Philadelphia 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 surgery lasting at least 2..5 hours. 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sevoflurane

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.
NCT00000261 Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-11-01 The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sevoflurane

Condition Name

Condition Name for Sevoflurane
Intervention Trials
Anesthesia 60
Postoperative Pain 35
Pain, Postoperative 13
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Condition MeSH

Condition MeSH for Sevoflurane
Intervention Trials
Pain, Postoperative 60
Delirium 34
Psychomotor Agitation 32
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Clinical Trial Locations for Sevoflurane

Trials by Country

Trials by Country for Sevoflurane
Location Trials
United States 98
Korea, Republic of 67
China 51
Egypt 43
Turkey 38
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Trials by US State

Trials by US State for Sevoflurane
Location Trials
Illinois 12
Ohio 12
New York 11
Texas 9
Massachusetts 7
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Clinical Trial Progress for Sevoflurane

Clinical Trial Phase

Clinical Trial Phase for Sevoflurane
Clinical Trial Phase Trials
Phase 4 241
Phase 3 49
Phase 2/Phase 3 23
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Clinical Trial Status

Clinical Trial Status for Sevoflurane
Clinical Trial Phase Trials
Completed 278
Recruiting 176
Not yet recruiting 113
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Clinical Trial Sponsors for Sevoflurane

Sponsor Name

Sponsor Name for Sevoflurane
Sponsor Trials
Yonsei University 21
Assiut University 15
Mansoura University 14
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Sponsor Type

Sponsor Type for Sevoflurane
Sponsor Trials
Other 799
Industry 37
NIH 3
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