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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

NCT04963036

Head and Neck Surgery Maxillofacial Surgery

UNKNOWN NA

The Hypotensive Effect of Propofol: an Observational Study

NCT01508351

Hypotension Anesthesia

COMPLETED

Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

NCT00393003

Postoperative Sedation

COMPLETED PHASE4

LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

NCT05136794

Opioid Free Anaesthesia Opioid Anaesthesia

COMPLETED

Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia

NCT06953193

Pancreatic Neoplasms Hypotension Pancreatoduodenectomy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation and Analgesia Monitoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Group Type EXPERIMENTAL

anesthesia guided by sedation and analgesia monitoring

Intervention Type PROCEDURE

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.

Control Group

Group Type PLACEBO_COMPARATOR

anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anesthesia guided by sedation and analgesia monitoring

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.

Intervention Type PROCEDURE

anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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;
* 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:

* Patients who meet one or more of the preoperative following criteria will not be included:
* acute heart failure or acute myocardial infarction;
* acute respiratory failure or pneumonia;
* septic shock;
* acute stroke;
* cardiac surgery;
* open chest surgery;
* opioid free anesthesia;
* intraoperative ketamine at a dose \> 0.2 mg.kg-1;
* lidocaine or dexmedetomidine by continuous infusion;
* refusal to participate in the study;

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David CHARIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU DE SAINT-ETIENNE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.