PURPOSE: Fospropofol disodium (FP) is a water-soluble prodrug of propofol with a differentiated pharmacokinetic and pharmacodynamic profile that distinguishes it from propofol lipid emulsion. FP has been studied for moderate sedation during diagnostic and therapeutic procedures, including colonoscopy and flexible bronchoscopy. A subset analysis of elderly (≥65 years) patients undergoing flexible bronchoscopy in a phase 3, randomized, double-blind study was performed.
METHODS: Patients (56% were ASA 3–4) received fentanyl citrate (50 mcg) followed by initial (4.88 mg/kg) and supplemental FP (1.63 mg/kg) doses (reduced 25% from the randomized 6.5 mg/kg dose). The primary endpoint was sedation success (3 consecutive Modified Observer's Assessment of Alertness/Sedation scores of ≤;4 and procedure completion without alternative sedative, assisted ventilation). Time to fully alert, patient satisfaction, and safety were also evaluated. Using Hopkins Verbal Learning Test-Revised, the patients' ability to remember word lists was also tested.
RESULTS: In the elderly subset (n = 61), sedation success was 92%, the mean time to fully alert was 8.0±10.9 min, and memory retention was 93% at screening and 72% during recovery. Nearly all (95%) patients were willing to be treated with FP again. Sedation-related hypoxemia (<90% for > 30 seconds) occurred in 20% of patients, however, the majority resolved with only increased oxygen flow (9/12). All of these patients had a history of COPD, pulmonary mass or other ongoing respiratory conditions. One patient with underlying severe hypoxemia and COPD required bag-masked ventilation but completed the procedure and was discharged afterwards.
CONCLUSION: FP provided safe and effective sedation, rapid time to fully alert, and high satisfaction in this elderly subset of patients undergoing flexible bronchoscopy. These findings need to be confirmed in a larger sample size.
CLINICAL IMPLICATIONS: Fospropofol holds promise as a sedative agent in bronchoscopy for an elderly population frequently with comorbid illness.
DISCLOSURE: Brad Vincent, No Financial Disclosure Information; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Fospropofol is in Phase IV research trials and has been submitted to the FDA for approval in endoscopic and minor surgical procedures.