What is the recommended usage timeframe for an opened bottle of propofol (2,6-diisopropylphenol)?

Propofol Usage Time Limits After Opening

An opened bottle of propofol must be discarded after 12 hours when used for ICU sedation, or after 6 hours when used for general anesthesia or MAC sedation procedures, due to risk of microbial contamination and subsequent infection. 1

Time Limits Based on Clinical Setting

The FDA-approved guidelines for propofol provide clear time limits that vary based on clinical context:

For General Anesthesia/MAC Sedation:

• Administration must commence promptly after opening and be completed within 6 hours 1
• Any unused portions must be discarded at the end of the procedure or at 6 hours, whichever occurs sooner 1

For ICU Sedation:

• Administration must commence promptly after opening and be completed within 12 hours after the vial has been spiked 1
• The tubing and any unused propofol must be discarded after 12 hours 1

Handling Requirements

Proper handling is critical to minimize infection risk:

• Strict aseptic technique must always be maintained during handling 1
• The vial rubber stopper should be disinfected using 70% isopropyl alcohol before access 1
• Propofol should be drawn into a sterile syringe immediately after opening 1
• When withdrawing propofol from vials, a sterile vent spike should be used 1
• The syringe should be labeled with appropriate information including the date and time the vial was opened 1

Microbial Contamination Risk

Propofol presents a significant infection risk due to its lipid emulsion formulation:

• Propofol is a single-access parenteral product that contains benzyl alcohol 1.5 mg/mL and sodium benzoate 0.7 mg/mL to inhibit microbial growth for up to 12 hours 1
• Despite these preservatives, it can still support microbial growth as it is not considered an antimicrobially preserved product under USP standards 1
• Studies have found bacterial contamination rates of 6.1% among propofol vials after clinical use, with some vials improperly used for extended periods (up to 72 hours) 2
• Research shows that storing opened propofol ampoules results in high bacterial contamination rates (20-26% at 12 hours), with diphtheroid bacilli and coagulase-negative staphylococci being the most frequent contaminants 3

Infection Prevention

To minimize infection risk:

• Propofol vials are never to be accessed more than once or used on more than one person 1
• The number of IV line manipulations should be minimized 1
• Administration lines should be changed after 12 hours 1
• Failure to use aseptic technique has been associated with microbial contamination, fever, infection/sepsis, and death 1

Clinical Implications

Proper handling of propofol is essential for patient safety:

• Propofol infusion syndrome is a rare but frequently fatal complication associated with prolonged administration (>48 hours) at high doses (>4 mg/kg/h) 4
• The occurrence of postoperative infections can be related to improper handling of propofol, making it an additional risk factor beyond surgical factors 5
• Hospital personnel involved in the preparation and handling of propofol must be educated on and adhere to manufacturer recommendations to prevent infection outbreaks 5

Strict adherence to these time limits and handling procedures is essential to minimize the risk of microbial contamination and subsequent patient infection.