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

Abstract

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.

Efficacy and Safety of Fospropofol Disodium for Injection in General Anesthesia Induction for Adult Patients: A Phase 3 Trial

“…Paresthesia was the most common AR in the Fospropofol FD group, similar to the results of other domestic and international clinical trials, and was transient and self-relieving with no residual symptom (Bengalorkar et al, 2011;Cohen, 2008;Dinis-Oliveira, 2018;Liu et al, 2016;Yen et al, 2013). The total incidence of abnormal sensation (paresthesia, 62.0%; diminished esthesia, 12.4%) in this trial was less than that in phase 2 (95.0%) at the same dose of Fospropofol FD (Liu et al, 2016).…”

Sedation in hypoalbuminemic geriatric patients under spinal anesthesia in hip surgery

“…The ideal sedative agent for use during regional anesthesia will provide sedation or sleep with reliable airway maintenance, have minimal circulatory and respiratory effects, and allow quick recovery without residual drowsiness. 12 Serum albumin levels play an important role in providing physiological hemostasis. With reduced albumin level damage to homeostatic functions may be observed, and may cause progression of pathological processes.…”

Thiopental to desflurane - an anaesthetic journey. Where are we going next?

“…30 Recently, nitrous oxide has emerged as a candidate therapy for treatment-resistant major depression. 31 32 Fospropofol This water-soluble propofol pro-drug 33 was developed to reduce the frequency of pain on injection during induction of anaesthesia/sedation and to offer a sustained period of hypnotic effect as the prodrug is progressively converted to propofol and formaldehyde. Regulatory insistence that its use be confined to those with anaesthesia competencies and an unfavourable adverse events profile including a proportion of patients experiencing burning perineal pain during administration, undermined its attractiveness to the clinical community 2 and it has now fallen out of use.…”