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

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.

Study Overview

• Status: Completed
• Conditions: Ambulatory Surgical Procedures; Ocular Anterior Segment Surgery
• Intervention / Treatment: Other: Health care organization (anesthetic surveillance)

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.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75019
      • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual surveillance; surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia.
Experimental: 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.	Other: Health care organization (anesthetic surveillance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during surgical procedure
patient pre-surgical stress	auto-assessment of stress level using a 0 to 10 (maximum stress) scale	baseline
pain during surgical procedure	retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale	within 10 minutes after surgery
patient satisfaction	auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale	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)	during surgical procedure
patient agitation	assessed by the surgeon using a 0 to 10 (very agitated) scale	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	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	at the end of a working day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
revision surgery	incidence rate of revision surgery within 24 hours	24 hours after baseline
efficiency of the centralised monitoring of anesthesic surveillance	assessment of costs	during surgical procedure
patient baseline pain	auto-assessment of patient pain before surgery on a 0 to 10 (maximum pain) scale	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Jean-Michel DEVYS, MD, Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimated): January 15, 2014

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SC_JMD_2013-1