Centralized monitored anesthesia care by nurse anesthetist for cataract and glaucoma surgery in a 1:3 ratio: a non-inferiority study.

BACKGROUND

Minor Ophthalmic Procedures (MOP), especially cataract or glaucoma surgery, are considered low risk. However, in France, anesthesia must be monitored continuously and carried out by an anesthetist or a nurse anesthetist (NA). The aim was to assess whether an externalized monitored anesthesia care (MAC) would be non-inferior to an individual MAC inside the OR regarding the incidence of severe hypertension, bradycardia, hypoxemia, and surgeon satisfaction.

METHODS

We performed a monocentric randomized, non-inferiority trial. Adults undergoing MOP with topical or locoregional anesthesia were randomly assigned to externalized MAC (the NA monitored simultaneously up to 3 patients with a screen monitor repeating the inside monitor) or inside MAC. The primary endpoint was a composite of per-operative complications defined as a blood pressure >200 mmHg, pulse rate <45/min, pulse oximetry <85%, or surgeon satisfaction regarding patient security <3/10. Secondary endpoints included patient and surgeons' overall satisfaction, re-operation within 24 hours, and nurses' overall satisfaction.

RESULTS

A total of 900 patients were enrolled (450 in both groups). The externalized MAC was non-inferior to inside MAC as event occurred in 29 patients (6.4%) and 26 patients (5.8%), respectively (adjusted difference - 0.7%). Patient agitation assessed by the surgeon was lower with the inside MAC (adjusted mean difference -0.33; 95%CI -0.61 to -0.04).

CONCLUSIONS

Among patients undergoing MOP with topical or locoregional anesthesia, an externalized MAC strategy with a 1:3 NA-to-patient ratio were non-inferior to an inside monitoring on the incidence of severe hypertension, bradycardia, hypoxemia and surgeon satisfaction regarding patient safety.