ADVERSE EVENTS IN A MULTICENTER PHASE-IV STUDY OF PROPOFOL - EVALUATION BY ANESTHESIOLOGISTS AND POSTANESTHESIA CARE UNIT NURSES

Phase II and III studies are tightly controlled trials investigating a dverse effects before government approval of a new drug. However, beca use postapproval Phase IV studies involve a much larger and more compl ex population, the true nature of adverse effects can be seen. We anal yzed Phase IV data for the new drug propofol with regard to the incide nce of adverse events, and evaluations of such events by anesthesiolog ists versus postanesthesia care unit (PACU) nurses. Data pertained to 25,981 patients, 1722 institutions, and 1819 anesthesiologists giving propofol in three anesthetic regimens. Inclusion criteria were liberal : age, 18-80 yr; ASA physical status I-III; no continuing pregnancy; a nd no prior adverse anesthetic experience. Anesthesiologists and PACU nurses used data collection forms to record demographic, perioperative , and outcome variables; to evaluate recovery (excellent, good, or poo r); and to describe adverse events. Adverse events were reported for 2 813 patients (10.8%); the most common events were pain on injection (5 .2%), hypotension (1.1%), nausea/vomiting (1.9%), and excitement (1.3% ). The incidences of pain on injection and nausea/vomiting were approx imately one-half and one-fifth, respectively, the values reported in e arlier studies. Six hundred thirty-three patients (2.4%) had a ''poor' ' recovery according to one or both of the evaluators (the anesthesiol ogist or PACU nurse). The PACU nurse was more influenced by nausea, vo miting, or postoperative pain; and the anesthesiologist was more influ enced by postoperative confusion or delayed emergence from anesthesia. For only 0.6% of patients did both evaluators rate recovery as poor. Anesthesiologists gave more weight to intraoperative adverse events, a nd nurses to postoperative events. Side effects troubling to patients were reported more frequently to/by nurses than anesthesiologists. We conclude that separate evaluations by anesthesiologists and nurses are useful in Phase IV studies, as each assesses different aspects of pat ient care.