Clinical trial NCT02037009: Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
Official title: Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgical Procedures
Ocular Anterior Segment Surgery
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Ministry of Health, France
First posted: 2014-01-15
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia

Exclusion Criteria:

* patient refusing to participate in the study or without health insurance

Primary outcomes:
measure: Anesthetic potential impact on surgery conditions
timeFrame: during surgical procedure
Secondary outcomes:
measure: interventions of the back-up anesthetic nurse
timeFrame: during surgical procedure
measure: patient pre-surgical stress
timeFrame: baseline
measure: pain during surgical procedure
timeFrame: within 10 minutes after surgery
measure: patient satisfaction
timeFrame: within 10 minutes after surgery
measure: incidence rate of each of the events included in the primary outcome
timeFrame: during surgical procedure
measure: patient agitation
timeFrame: within 10 minutes after surgery
measure: operating conditions
timeFrame: within 10 minutes after surgery
measure: working conditions
timeFrame: at the end of a working day
Other outcomes:
measure: revision surgery
timeFrame: 24 hours after baseline
measure: efficiency of the centralised monitoring of anesthesic surveillance
timeFrame: during surgical procedure
measure: patient baseline pain
timeFrame: baseline
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile de France
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Jean-Michel DEVYS, MD
role: PRINCIPAL_INVESTIGATOR
References: