A comparative study of non-lipid nanoemulsion of propofol with solutol and propofol emulsion with lecithin.

OBJECTIVE

Some formulations have been proposed to reduce the adverse reactions due to the lipid emulsion containing soybean oil used as propofol carrier. This study for endoscopy sedation was aimed at evaluating and comparing the safety, effectiveness and adverse effects of the use of propofol nanoemulsion compared to propofol currently commercialized.

METHODS

In this prospective study, 150 patients were submitted to upper digestive endoscopy. These patients were allocated into two groups: the control group (CONT Group; n=75) and the nanoemulsion group (NE Group; n=75). HR, SBP, DBP, SpO(2) and BIS (which is considered to be appropriate between 65 and 75 during procedure) were monitored. Gender, age, weight, height, BMI, ASA physical status, times and doses were analyzed, as well as adverse effects (phlogistic signs and pain on injection, apnea, nausea/vomiting) and alterations in monitoring variables. A p-value < 0.05 was considered significant.

RESULTS

The groups had similar results concerning anthropometric data and physical status. None of the patients developed apnea or presented phlogistic signs in the injection site. The incidence of pain on injection in the CONT Group was 82.7% and 53.3% in the NE Group (p<0.001), and the incidence of nausea and vomiting was 10.7% in the CONT Group and 2.7% in the NE Group (p>0.05). The times, induction doses and the SBP and DBP values at the end of examination and at the moment of discharge from the PACU were lower in the NE Group (p<0.05).

CONCLUSIONS

Lipid propofol and propofol nanoemulsion were equivalent concerning effectiveness, safety and adverse effects in the doses used. There was a lower incidence of pain on injection in the nanoemulsion formulation.