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Sedation and Analgesia MonitoringOPTI-TWONCT05893030

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

A study testing anesthesia guided by sedation and analgesia monitoring and anesthesia performed according only to the clinical judgment of the anesthetist as usual practice in people with Sedation and Analgesia Monitoring, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Sedation and Analgesia Monitoring
What is being tested?
anesthesia guided by sedation and analgesia monitoring and anesthesia performed according only to the clinical judgment of the anesthetist as usual practice
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,132 participants
Where
20 sitesFrance
Study dates
12 Oct 2023to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • patients affiliated to the French Social Security;
  • informed and signed consent to participating in the study;
  • planned postoperative hospitalization > 48 hours;
  • patients over 75 years of age with at least one of the following postoperative risk factors:
  • ischemic coronary disease;
  • history of compensated or prior heart failure;
Show all 31Show fewer
  • stroke;
  • significant arrhythmias: fibrillation or auricular flutter with ventricular response > 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);
  • peripheral vascular disease;
  • chronic obstructive pulmonary disease;
  • chronic respiratory failure;
  • renal insufficiency, defined by a creatinine > 175 µmol.l-1 (2 mg.dl-1);
  • insulin therapy for diabetes;
  • active cancer;
  • chronic alcohol abuse;
  • dementia.
  • elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device
  • Non inclusion criteria:
  • Patients who meet one or more of the preoperative following criteria will not be included:
  • acute heart failure or acute myocardial infarction;
  • complete arrhythmia due to atrial fibrillation;
  • acute respiratory failure or pneumonia;
  • septic shock;
  • acute stroke;
  • cardiac surgery;
  • open chest surgery;
  • opioid free anesthesia;
  • intraoperative ketamine at a dose > 0.25 mg.kg-1; > 0.25 mg/kg or or intravenous electric syringe
  • lidocaine or dexmedetomidine by continuous infusion;
  • refusal to participate in the study;
  • patient under guardianship, conservatorship, or unable to understand the study.

Who cannot join

None listed.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

David CHARIER, MD, PhD contact

+33.4.77.82.85.65

david.charier@chu-st-etienne.fr

Marlène BONNEFOI, CRA contact

(0)477828822 ext. +33

marlene.bonnefoi@chu-st-etienne.fr

20 sites in 1 country

France20 sites, 20 recruiting

  • Chu D'Amiens Picardie

    Amiens, 80054

    Hervé DUPONT, MD PhD

    Recruiting

  • Clinique Victor Pauchet

    Amiens, 80090

    Pierre HUETTE, MD

    Recruiting

  • Chru de Besancon

    Besançon, 25030

    Guillaume BESCH, MD PhD

    Not yet recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

    Philippe RICHEBE, MD, PhD

    Recruiting

  • Hôpital de La Cavale Blanche

    Brest, 29200

    Anaïs CAILLARD, PhD

    Not yet recruiting

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63000

    Bertille PAQUETTE, MD

    Not yet recruiting

  • Chu de Grenoble

    Grenoble, 38700

    Pierre BOUZAT, MD PhD

    Not yet recruiting

  • Chu de Lille

    Lille, 59037

    Gilles LEBUFFE, MD PhD

    Recruiting

  • APHM - Centre Hôpital Marseille Nord

    Marseille, 13015

    Marc LEONE, MD PhD

    Not yet recruiting

  • Chu de Nantes

    Nantes, 44093

    Raphaël CINOTTI, MD PhD

    Not yet recruiting

  • Hôpital l'Archet

    Nice, 06200

    Romain ROZIER, MD

    Not yet recruiting

  • Chu de Nimes

    Nîmes, 30000

    Yann GRICOURT, MD

    Philippe CUVILLON, MD PhD

    Recruiting

  • Hopital Bichat Claude Bernard

    Paris, 75018

    Aurélie GOUEL, MD

    Recruiting

  • Chu Lyon Sud

    Pierre-Bénite, 69495

    Arnaud FRIGGERI, MD, PhD

    Recruiting

  • Chu de Poitiers

    Poitiers, 86000

    Matthieu BOISSON, MD

    Recruiting

  • Hôpital Saint Charles

    Saint-Dié, 88100

    Claude MEISTELMAN, MD, PhD

    Not yet recruiting

  • Chu St-Etienne

    Saint-Etienne, 42100

    Serge MOLLIEX, MD, PhD

    David CHARIER, MD, PhD

    Recruiting

  • Chu de Toulouse

    Toulouse, 31059

    Fabrice FERRE, MD PhD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Cyrus MOTAMED, MD

    Not yet recruiting

  • Médipole Lyon Villeurbanne

    Villeurbanne, 69100

    Vincent COLLANGE, MD

    Recruiting

Other trials in France

About this study

Official title: Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.

Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.

The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.

Being tested
anesthesia guided by sedation and analgesia monitoring, anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anesthesia guided by sedation and analgesia monitoringProcedure or surgery

    Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by

    • Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0;
    • or SedLine® Sedation Monitor : Patient State Index (PSi) between 25 and 50;
    • or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0; and the level of nociception by :
    • Nociception monitor PMD-200® : Nociception Level (NoL) between 10 and 25.

  • anesthesia performed according only to the clinical judgment of the anesthetist as usual practiceProcedure or surgery

    Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring

Study groups in NCT05893030
Study groupRoleWhat they receive
Intervention GroupExperimentalNot described
Receives: Procedure: anesthesia guided by sedation and analgesia monitoring
Control GroupPlacebo comparatorNot described
Receives: Procedure: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. death

    Measured: Day 30

  2. Postoperative acute kidney injury (PO-AKI)

    The PO-AKI will be defined as an increase to 1.5 times the reference level, or as more than 0.3 mg.dl-1 (i.e. 26.5 µmol.l-1) between the last preoperative value and the maximal value observed after surgery, or urine volume < 0.5 ml.kg-1.h-1 for 6 hours, according to the recommendations of the Acute Kidney Injury Network

    Measured: Day 30

  3. cardiovascular complication

    postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation

    Measured: Day 30

  4. neurological complication

    Stroke or transient ischemic attack

    Measured: Day 30

  5. Post-operative delirium (POD)

    Post-operative delirium (POD) will be evaluated using the 3-minute Diagnostic Confusion Assessment Method (3D-CAM), appropriated and validated for the assessment of delirium in the postoperative period, or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for the intubated patients.

    Measured: Day 30

Secondary outcomes (14)

  1. doses of hypnotics administered

    Measured: during surgery

  2. doses opioids administered;

    Measured: during surgery

  3. number and duration of hypotensive periods

    an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.

    Measured: during surgery

  4. time spent within the desired range of sedation:

    Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0 or SedLine® Sedation Monitor : Patient State Index (PSI) between 25 and 50 AND Suppression Ratio (SR) at 0 or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0 The anesthetist will have access to the value of sedation monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.

    Measured: during surgery

  5. time spent within the desired range of analgesia:

    Nociception monitor PMD-200® : Nociception Level (NOL) between 10 and 25. The anesthetist will have access to the value of sedation and analgesia monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.

    Measured: during surgery

  6. doses of vasopressive amines (ephedrine or norepinephrine) administered;

    Measured: during surgery

  7. pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)

    VAS 0 to 10 [0 corresponds to no pain - 10 corresponds to maximum pain]

    Measured: At 48 Hours after surgery

  8. dose of opioid administered;

    Measured: At 48 Hours after surgery

  9. incidence of awareness and recall during anesthesia (explicit memory).

    Measured: At 48 Hours after surgery

  10. acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)

    Measured: Day 30

  11. duration of stay in Intensive Care Unit (ICU);

    Measured: Day 30

  12. rate of unexpected ICU admission, or readmission

    Measured: Day 30

  13. duration of hospital stay;

    Measured: Day 30

  14. early hospital readmission rate

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start12 Oct 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893030
Sponsor's protocol ID
20PH283
Other IDs
ANSM
Acronym
OPTI-TWO
Status last verified
Oct 2026
First submitted
22 May 2023
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing anesthesia guided by sedation and analgesia monitoring and anesthesia performed according only to the clinical judgment of the anesthetist as usual practice in people with Sedation and Analgesia Monitoring, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David CHARIER, MD, PhD (+33.4.77.82.85.65, david.charier@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

death (time frame: Day 30). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05893030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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