An interventional study of Health care organization (anesthetic surveillance) in Ambulatory Surgical Procedures and Ocular Anterior Segment Surgery, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Health services research
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.
In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.
In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.
The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.
The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.
Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia.
1 anesthetic nurse is posted at a centralised monitoring station outside of the 3 operating rooms, while another one can intervene inside the 3 operating rooms whenever needed. Interphones allow communication between the monitoring station and the operating rooms.
Other: Health care organization (anesthetic surveillance)
Anesthetic potential impact on surgery conditions
Incidence rate of at least 1 of the following events, during surgery: * blood pressure \> 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) * cardiac frequency \< 45/min for at least 1 mn * SaO2 \<85% for at least 1 mn * poor operating conditions (rated ≤ 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.
Time frame: during surgical procedure
interventions of the back-up anesthetic nurse
mean number of interventions of the back-up anesthetic nurse during the procedures proportion of surgical procedures requiring at least one intervention of the nurse
Time frame: during surgical procedure
patient pre-surgical stress
auto-assessment of stress level using a 0 to 10 (maximum stress) scale
Time frame: baseline
pain during surgical procedure
retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale
Time frame: within 10 minutes after surgery
patient satisfaction
auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale
Time frame: within 10 minutes after surgery
incidence rate of each of the events included in the primary outcome
incidence rate of blood pressure \> 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) incidence rate of cardiac frequency \< 45/min for at least 1 mn incidence rate of SaO2 \<85% for at least 1 mn incidence rate of poor operating conditions (rated \< 7 by the surgeon, on a numeric scale from 0 to 10 (excellent conditions)
Time frame: during surgical procedure
patient agitation
assessed by the surgeon using a 0 to 10 (very agitated) scale
Time frame: within 10 minutes after surgery
operating conditions
auto-assessment by the surgeon of the operating conditions, on a 0 to 10 (excellent conditions) scale and on a 0 to 10 (completely safe) scale
Time frame: within 10 minutes after surgery
working conditions
auto-assessment of working conditions by the anesthetic nurses, on a 0 to 10 (excellent) scale and on a 0 to 10 (completely safe) scale
Time frame: at the end of a working day
revision surgery
incidence rate of revision surgery within 24 hours
Time frame: 24 hours after baseline
efficiency of the centralised monitoring of anesthesic surveillance
assessment of costs
Time frame: during surgical procedure
patient baseline pain
auto-assessment of patient pain before surgery on a 0 to 10 (maximum pain) scale
Time frame: baseline
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Fondation Ophtalmologique Adolphe de Rothschild