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.
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
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.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Chu D'Amiens Picardie
Amiens, 80054
Hervé DUPONT, MD PhD
- Recruiting
Clinique Victor Pauchet
Amiens, 80090
Pierre HUETTE, MD
- Not yet recruiting
Chru de Besancon
Besançon, 25030
Guillaume BESCH, MD PhD
- Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Philippe RICHEBE, MD, PhD
- Not yet 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
- Recruiting
Chu de Lille
Lille, 59037
Gilles LEBUFFE, MD PhD
- Not yet 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
- 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
- Not yet recruiting
Hôpital Saint Charles
Saint-Dié, 88100
Claude MEISTELMAN, MD, PhD
- 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
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
Cyrus MOTAMED, MD
- Recruiting
Médipole Lyon Villeurbanne
Villeurbanne, 69100
Vincent COLLANGE, MD
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.
- Conditions
- Sedation and Analgesia Monitoring
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Procedure: anesthesia guided by sedation and analgesia monitoring |
| Control Group | Placebo comparator | Not 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.
death
Measured: Day 30
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
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
neurological complication
Stroke or transient ischemic attack
Measured: Day 30
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)
doses of hypnotics administered
Measured: during surgery
doses opioids administered;
Measured: during surgery
number and duration of hypotensive periods
an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.
Measured: during surgery
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
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
doses of vasopressive amines (ephedrine or norepinephrine) administered;
Measured: during surgery
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
dose of opioid administered;
Measured: At 48 Hours after surgery
incidence of awareness and recall during anesthesia (explicit memory).
Measured: At 48 Hours after surgery
acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)
Measured: Day 30
duration of stay in Intensive Care Unit (ICU);
Measured: Day 30
rate of unexpected ICU admission, or readmission
Measured: Day 30
duration of hospital stay;
Measured: Day 30
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.
- First posted7 Jun 2023
- Study start12 Oct 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and Analgesia MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, PhD, Principal investigator, CHU DE SAINT-ETIENNE
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