Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

NCT ID: NCT02037009

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-08-31

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.

Conditions

Ambulatory Surgical Procedures; Ocular Anterior Segment Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual surveillance

surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia.

Group Type: NO_INTERVENTION

No interventions assigned to this group

centralised monitoring surveillance

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.

Group Type: EXPERIMENTAL

Health care organization (anesthetic surveillance)

Intervention Type: OTHER

Interventions

Health care organization (anesthetic surveillance)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel DEVYS, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, France

Countries

France

References

Clariot S, Moures JM, Lopes L, Gatinel D, Gabison E, Nicolaos G, Salomon L, Devys JM. Centralized monitored anesthesia care by nurse anesthetist for cataract and glaucoma surgery in a 1:3 ratio: a non-inferiority study. Minerva Anestesiol. 2025 Mar;91(3):176-183. doi: 10.23736/S0375-9393.24.18455-6. Epub 2024 Dec 4.

Reference Type: RESULT

PMID: 39630143 (View on PubMed)

Other Identifiers

SC_JMD_2013-1

Identifier Type: -

Identifier Source: org_study_id