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NCT Number: NCT02037009

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

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.

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Key information

Conditions

Ambulatory Surgical Procedures Ocular Anterior Segment Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health care organization (anesthetic surveillance)

Other

Primary outcomes

  1. Anesthetic potential impact on surgery conditions

    Time frame: during surgical procedure

    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.

Secondary outcomes

  1. interventions of the back-up anesthetic nurse

    Time frame: during surgical procedure

    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

  2. patient pre-surgical stress

    Time frame: baseline

    auto-assessment of stress level using a 0 to 10 (maximum stress) scale

  3. pain during surgical procedure

    Time frame: within 10 minutes after surgery

    retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale

  4. patient satisfaction

    Time frame: within 10 minutes after surgery

    auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale

  5. incidence rate of each of the events included in the primary outcome

    Time frame: during surgical procedure

    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)

  6. patient agitation

    Time frame: within 10 minutes after surgery

    assessed by the surgeon using a 0 to 10 (very agitated) scale

  7. operating conditions

    Time frame: within 10 minutes after surgery

    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

  8. working conditions

    Time frame: at the end of a working day

    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

Other outcomes

  1. revision surgery

    Time frame: 24 hours after baseline

    incidence rate of revision surgery within 24 hours

  2. efficiency of the centralised monitoring of anesthesic surveillance

    Time frame: during surgical procedure

    assessment of costs

  3. patient baseline pain

    Time frame: baseline

    auto-assessment of patient pain before surgery on a 0 to 10 (maximum pain) scale

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • Ministry of Health, France

Registry information

Acronym: SACHS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2014
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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