NCT02037009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2014

Last Update Submit

January 2, 2026

Conditions

Ambulatory Surgical ProceduresOcular Anterior Segment Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    during surgical procedure

Secondary Outcomes (8)

  • interventions of the back-up anesthetic nurse

    during surgical procedure

  • patient pre-surgical stress

    baseline

  • pain during surgical procedure

    within 10 minutes after surgery

  • patient satisfaction

    within 10 minutes after surgery

  • incidence rate of each of the events included in the primary outcome

    during surgical procedure

  • +3 more secondary outcomes

Other Outcomes (3)

  • revision surgery

    24 hours after baseline

  • efficiency of the centralised monitoring of anesthesic surveillance

    during surgical procedure

  • patient baseline pain

    baseline

Study Arms (2)

Usual surveillance

NO INTERVENTION

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

centralised monitoring surveillance

EXPERIMENTAL

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)

Interventions

Health care organization (anesthetic surveillance)OTHER
centralised monitoring surveillance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

Related Publications (1)

  • 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.

    PMID: 39630143RESULT

Study Officials

  • Jean-Michel DEVYS, MD

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

FR(1)