Letters to the Editor: Letters & Announcements
To the Editor:
We were interested in the case report on extravasation injuries in perioperative setup (1). The authors mentioned that even large amounts of propofol cause no damage on extravasation. However, propofol is associated with extravasation injury (2). Various new formulations of propofol are in vogue with alteration in one component or another, which may alter its physical characteristics (3,4). Recently, one such new formulation of propofol, Cleofol® 1% (Themis Medicare, Mumbai, India), became available in India. It has been recommended for use in patients who demand vegetarian anesthesia (5).
We report a case of extravasation injury associated with use of Cleofol. A 48-yr-old female was scheduled for diagnostic dilation and curettage. After placement of routine monitors, an 18-gauge IV cannula was inserted in the most prominent vein on the dorsum of the left hand. Anesthesia was induced with cleofol 10 mL (premixed with lidocaine) after administration of meperidine 50 mg, and anesthesia was maintained with nitrous oxide and halothane 1.5%-2% in oxygen. The procedure was uneventful. In the postanesthesia care unit, extravasation was observed. The patient complained of severe pain in her left hand. The skin was erythematous and swollen. Radial pulse was well palpable. Considering the extravasation injury, her left upper limb was elevated. Subcutaneous hylauronidase was injected. Over the next 4 h, edema increased and the hand was swollen, tense, and cyanotic with delayed capillary refill. Surgical opinion was sought. The skin of the dorsum of the left hand was incised and saline flush out was performed with 500 mL of normal saline and drains were inserted for 24 h. A layer of betadine soaked gauge was applied to the wound. Four weeks later, the site of extravasation had healed well without any undo sequelae.
Cleofol is being marketed as “clear propofol” without any mention of its composition or solvent used. This clear solution contains 10 mg of propofol and excipients to make 1 mL of the preparation. The details of the excipients are not available in the product information. The product information states that there is minimal pain on injection, thrombosis and phlebitis are rare on accidental extravasation, and intra-arterial injection in animals showed minimal tissue reaction. The manufacturers claim that an “open multicentric trial” was conducted before its introduction (reference not given) and that United States patent has been granted. This formulation has been cleared for use in clinical practice by the Drug Controller of India (6). However, its use has been reported to be associated with very high incidence of severe pain (7). Cleofol is also known to damage the bivalve used for administration (6); this has so far not been a problem with the lipid emulsion preparations. This report recommends a judicious use of modified formulations of propofol, as any change in one of the components may alter the safety profile and physical characteristics (2,3), making a potentially innocuous drug a strong vesicant.
Rajesh Mahajan, MD
Rahul Gupta, MD
Anju Sharma, MD
Department of Anesthesia, ASCOMS, Jammu, India, email@example.com, firstname.lastname@example.org
1. Schummer W, Schummer C, Bayer O, et al. Extravasation injury in the perioperative setting. Anesth Analg 2005;100:722-7.
2. Tokumine J, Sugahara K, Tomori T, et al. Tissue necrosis caused by extravasated propofol. J Anesth 2002;16:358-9.
3. Song D, Hamza M, White PF, et al. The pharmacodynamic effects of a lower-lipid emulsion of propofol: a comparison with the standard propofol emulsion. Anesth Analg 2004;98:687-91.
4. Paul M, Dueck M, Kampe S, et al. Pharmacological characteristics and side effects of a new galenic formulation of propofol without soyabean oil. Anaesthesia 2003;58:1056-62.
5. Munjal M, Sood D, Gupta VK, Singh A. Use of vegetarian propofol in Jain community of India. Anaesthesia 2004;58:1137.
6. Puri GD, Singh KP. Damage to the three way valves by a clear propofol formulation. Anesth Analg 2004;98:1193-4.
7. Sood D, Tewari A, Katyal S, et al. Pain on injection of cleofol. Anaesthesia 2005;60:521-2.