A Randomized, Double-blind, Phase 3 Study of Fospropofol Disodium for Sedation During Colonoscopy

Cohen, Lawrence B.; Cattau, Edward L.; Goetsch, Allen C.; Shah, Atul K.; Weber, John R.; Rex, Douglas K.; Kline, Jacqueline

doi:10.1097/mcg.0b013e3181c2987e

Cited by 43 publications

(31 citation statements)

References 13 publications

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“…COHEN and co-workers [76,77] conducted two randomised controlled trials of fospropofol or midazolam following premedication with fentanyl for colonoscopy and found that a dose of 6.5 mg?kg -1 provided appropriate sedation and high patient satisfaction. SILVESTRI et al [6] conducted a phase III randomised controlled trial of fospropofol 2 mg?kg -1 and 6.5 mg?kg -1 (those .65 years of age or with ASA category 3 or 4 had the dose reduced by 25%) .…”

Section: Emerging Pharmacological Sedatives In Bronchoscopy Fospropofolmentioning

confidence: 99%

“…Blood levels of propofol after administration of fospropofol reach lower peak levels and are more sustained than after administration of intravenous propofol leading to predictable levels of moderate sedation [74]. The advantage of its use is that it does not cause pain on injection, does not have the high risk of bacterial contamination seen with propofol and leads to predictable levels of sedation, however, it has the disadvantage that if a patient is over sedated they will require ventilatory support for longer and is associated with the commonly reported adverse effects paraesthesiae and pruritus [75,76].…”

Section: Emerging Pharmacological Sedatives In Bronchoscopy Fospropofolmentioning

confidence: 99%

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Sedation for flexible bronchoscopy: current and emerging evidence

José¹,

Shaefi²,

Navani³

2013

Eur Respir Rev

103

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Flexible bronchoscopy is commonly performed by respiratory physicians and is the gold standard for directly visualising the airways, allowing for numerous diagnostic and therapeutic interventions. With the widespread use of flexible bronchoscopy and the evolution of interventional bronchoscopy with more complex and longer procedures, physicians are placing increasing importance on the use of sedation as a necessary adjunct to topical anaesthesia. There is no standardised practice for the use of sedation in bronchoscopy with a good deal of variation among physicians regarding the use of pre-procedure medication and pharmacological sedatives. In addition, there is ongoing debate and controversy about proceduralist-administered versus anaesthetist-administered sedation whilst at the same time there is a growing body of evidence that nonanaesthetist administered sedation is safe and cost-effective. In this review we summarise the evidence for the use of sedation as an adjunct to topical anaesthesia in bronchoscopy and provide the clinician with up-todate concise guidance for the use of pharmacological sedatives in bronchoscopy and future directions for sedation in the bronchoscopy suite.

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Section: Emerging Pharmacological Sedatives In Bronchoscopy Fospropofolmentioning

confidence: 99%

Section: Emerging Pharmacological Sedatives In Bronchoscopy Fospropofolmentioning

confidence: 99%

Sedation for flexible bronchoscopy: current and emerging evidence

José¹,

Shaefi²,

Navani³

2013

Eur Respir Rev

103

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“…8 Researchers have demonstrated higher rates of sedation success, less need for supplemental pain medication during sedation, and increased patient and physician satisfaction. [8][9][10][11] Sedation success rates of 87 to 89% for fospropofol have been cited, versus approximately 69% for midazolam. 5,9 Patient satisfaction was found to be 92.3% with fospropofol compared to 69.2% with midazolam, and physician satisfaction was almost 3 times higher with fospropofol.…”

mentioning

confidence: 99%

“…[8][9][10][11] Sedation success rates of 87 to 89% for fospropofol have been cited, versus approximately 69% for midazolam. 5,9 Patient satisfaction was found to be 92.3% with fospropofol compared to 69.2% with midazolam, and physician satisfaction was almost 3 times higher with fospropofol. 5,9 To date, published studies have focused on comparing the 2 sedative agents during either colonoscopy or bronchoscopy procedures; the use of such drugs in dentistry has yet to be studied.…”

mentioning

confidence: 99%

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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“…Phase II and III clinical trials showed faster recovery and greater patient satisfaction after sedation with fospropofol in comparison with midazolam. 27 Fospropofol causes less pain on injection than propofol, but is associated with a greater incidence of perineal paresthesia or pain. Fospropofol disodium has been approved by the US Food and Drug Administration for monitored anesthesia care in adults.…”

Section: Novel Propofol Derivativementioning

confidence: 99%

Propofol for gastrointestinal endoscopy

Nishizawa

Suzuki

2018

UEG Journal

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Most gastrointestinal endoscopic procedures are now performed with sedation. Moderate sedation using benzodiazepines and opioids continues to be widely used, but propofol sedation is becoming more popular because its unique pharmacokinetic properties make endoscopy almost painless, with a very predictable and rapid recovery process. There is controversy as to whether propofol should be administered only by anesthesia professionals. According to published values, endoscopist-directed propofol has a lower mortality rate than endoscopist-delivered benzodiazepines and opioids, and a comparable rate to general anesthesia by anesthesiologists. Rapid recovery has a major impact on patient satisfaction, post-procedure education and the general flow of the endoscopy unit. According to estimates, the absolute economic benefit of endoscopist-directed propofol implementation in a screening setting is probably substantial, with 10-year savings of $3.2 billion in the USA. Guidelines concerning the use of propofol emphasize the need for adequate training and certification in sedation by non-anesthetists.

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A Randomized, Double-blind, Phase 3 Study of Fospropofol Disodium for Sedation During Colonoscopy

Abstract: The fospropofol 6.5-mg/kg dosing regimen was well tolerated and effective for sedation during colonoscopy and was associated with higher rates of sedation success, memory retention, and physician satisfaction than the fospropofol 2-mg/kg dose.

Cited by 43 publications

References 13 publications

Sedation for flexible bronchoscopy: current and emerging evidence

Sedation for flexible bronchoscopy: current and emerging evidence

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

Propofol for gastrointestinal endoscopy

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