Safety evaluation of fospropofol for sedation during minor surgical procedures

Gan, Tong J.; Berry, Bradley D.; Ekman, Evan F.; Muckerman, Richard C.; Shore, Neal D.; Hardi, Robert

doi:10.1016/j.jclinane.2009.08.007

Cited by 27 publications

(20 citation statements)

References 15 publications

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“…The major drawbacks with midazolam are its slow onset, inadequate alleviation of procedure-related discomfort, increased depth of sedation required for amnesia, and potentially prolonged recovery time. 1,2 Propofol is a sedative/hypnotic agent known for its rapid onset and short duration of action, as well as its antiemetic, amnestic, and hypnotic effects. There are several limitations with routine usage of propofol, the most crucial being that in certain patients, propofol can cause cardiac and respiratory depression with possible loss of airway reflexes in doses commonly used for moderate sedation.…”

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confidence: 99%

“…Per its manufacturer and the US Food and Drug Administration (FDA), propofol is recommended for use only by those trained in administering general anesthesia; it is also not advised for use by practitioners who act as both the anesthetist and the surgeon. 1 Thus, propofol is not necessarily appropriate for the operatoranesthetist model for moderate sedation, in which the surgeon and anesthetist are one and the same. Additional limitations of propofol include its lipidemulsion formulation, which frequently causes pain on injection.…”

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confidence: 99%

“…Due to the necessary enzymatic conversion, the blood concentration of propofol liberated from fospropofol increases at a slower rate, exhibits a longer duration, and does not reach the same peaks as direct injections of propofol. 1,5,6 The rate of increase of the liberated propofol depends more on the rate-limited metabolism of fospropofol than on the rate of the injection of the prodrug itself. 7 These pharmacokinetic properties retard the negative side effects of propofol and potentially create a wider margin of safety.…”

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confidence: 99%

“…Fospropofol is associated with less cardiorespiratory depression than propofol. 1 In one safety and efficacy study of patients receiving 6.5 mg/kg doses of fospropofol, less than 1% experienced apnea, 4% demonstrated hypoxemia, and 4% became hypotensive. 4 This slow and steady release of propofol from fospropofol may reduce the risk of oversedation and thus makes the safety profile of fospropofol potentially superior to that of propofol.…”

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confidence: 99%

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A Comparison of Fospropofol to Midazolam for Moderate Sedation During Outpatient Dental Procedures

Yen¹,

Prior

Riley

et al. 2013

Anesthesia Progress

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Moderate intravenous (IV) sedation combined with local anesthesia is common for outpatient oral surgery procedures. An ideal sedative agent must be safe and well tolerated by patients and practitioners. This study evaluated fospropofol, a relatively new sedative/hypnotic, in comparison to midazolam, a commonly used benzodiazepine, for IV moderate sedation during oral and maxillofacial surgery. Sixty patients were randomly assigned to either the fospropofol or the midazolam group. Each participant received 1 μg/kg of fentanyl prior to administration of the selected sedative. Those in the fospropofol group received an initial dose of 6.5 mg/kg, with 1.6 mg/kg supplemental doses as needed. Those in the midazolam group received initial doses of 0.05 mg/kg, followed by 0.02 mg/kg supplemental doses. The quality of sedation in each patient was evaluated with regard to (a) onset of sedation, maintenance, and recovery profile; (b) patient and surgeon satisfaction; and (c) hemodynamic stability and adverse effects. The fospropofol group demonstrated shorter physical recovery times than midazolam patients, taking a mean of 11.6 minutes versus 18.4 minutes for physical recovery (P = .007). Cognitive recovery comparison did not find any difference with a mean of 7.5 minutes versus 8.8 minutes between the 2 drug groups (P = .123). The fospropofol group had a higher rate of local anesthetic injection recall (90.5 vs 44.4%, P = .004). Other parameters of recall were comparable. Two adverse effects demonstrated significance, with more patients in the midazolam group experiencing tachycardia (48.2 vs 9.4%, P = .001), and more patients in the fospropofol group experiencing perineal discomfort (40.6 vs 0, P < .001). No significant difference was found in any other measures of sedation safety, maintenance, or satisfaction. Fospropofol, when administered intravenously by a dentist anesthesiologist at the indicated dose in this study, appears to be a safe, well-tolerated alternative to midazolam for intravenous moderate sedation during minor oral surgery procedures.

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confidence: 99%

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confidence: 99%

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confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

A Comparison of Fospropofol to Midazolam for Moderate Sedation During Outpatient Dental Procedures

Yen¹,

Prior

Riley

et al. 2013

Anesthesia Progress

View full text Add to dashboard Cite

show abstract

“…Fospropofol produces a predictable pharmacokinetic and pharmacodynamic profile by delivering controlled sedation in an outpatient setting. The approval of fospropofol as a sedative-hypnotic agent for monitored anaesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures is currently pending [18]. However, experimental or pharmacological evaluation of the analgesic effects of fospropofol-alfentanil combination administration in short surgical procedures or animal experiments has not been reported.…”

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confidence: 99%

Synergistic antinociceptive interactions between fospropofol and alfentanil in mice

Zhao

Jia

Wang

et al. 2015

Pharmacological Reports

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Directed glia‐assisted angiogenesis in a mature neurosensory structure: Pericytes mediate an adaptive response in human dental pulp that maintains blood‐barrier function

Farahani

Sarrafpour

Simonian

et al. 2012

J of Comparative Neurology

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The specialized tightly controlled microcirculation of craniofacial neurosensory organs is an essential evolutionary adaptation and yet a dilemma where angiogenic remodeling occurs. Despite extreme plasticity of neurosensory structures, the capacity to reconcile barrier phenotype of the microcirculation with an angiogenic cascade is not known. Here we provide primary evidence for such a response in an elemental neurosensory structure, human dental pulp, following chronic carious insult. In response to hypoxic challenge neurosensory odontoblasts express hypoxia-inducible factor-1α and notch-1. Associated radial rearrangement of astrocyte-like telacytes that communicate through a cell-poor zone with the microvasculature is observed. Activated pericytes characterized by expression of α-smooth muscle actin are located adjacent to the telacyte attachment to the vasculature. In this location, endothelial expression of sonic hedgehog parallels expression of notch-1 by pericytes. The angiogenic response is initiated by pericyte contraction and altered endothelial polarity and proliferation leading to intussusception of endothelial cells and extensive remodeling of basement membrane with upregulation of laminin-8 and laminin-5. These responses guide intravascular loop formation that maintains both intact basement membrane and tight junctions. This initial phase is followed by formation of anastomoses that enhance the hemodynamic capacity of the intravascular loops. The formation of anastomoses is mediated by extension of cytonemes from pericytes guided by MHC-II(+)/CD-163(+) microglia aligned with the telacytes. The cytonemes seek out pericytes on adjacent intravascular loops to initiate migration of endothelial cells. These findings support a new paradigm for understanding angiogenic capacity of neurosensory structures and aberrations of this response manifest as neurovasculopathies.

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Safety evaluation of fospropofol for sedation during minor surgical procedures

Cited by 27 publications

References 15 publications

A Comparison of Fospropofol to Midazolam for Moderate Sedation During Outpatient Dental Procedures

A Comparison of Fospropofol to Midazolam for Moderate Sedation During Outpatient Dental Procedures

Synergistic antinociceptive interactions between fospropofol and alfentanil in mice

Directed glia‐assisted angiogenesis in a mature neurosensory structure: Pericytes mediate an adaptive response in human dental pulp that maintains blood‐barrier function

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