Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent. Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine). Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
Opioid-free anesthesia
Opioid anesthesia
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Beaujon Hospital
Clichy, France
Lille University Hospital
Lille, France
Metz-Thionville Hospital
Metz, France
Montpellier University Hospital
Montpellier, France
Nantes University Hospital
Nantes, France
Nimes University Hospital
Nîmes, France
Perigueux Hospital
Périgueux, France
Rennes University Hospital
Rennes, France
Saint-Brieuc Hospital
Saint-Brieuc, France
...and 1 more locations
Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD).
Postoperative hypoxemia is defined as an oxygen saturation (SpO2) \< 95% with a need for oxygen supplementation within the first 48h after extubation; the duration of oxygen treatment will also be recorded. Postoperative ileus is defined as an absence of flatus or stools within the first 48h after extubation. Postoperative cognitive dysfunction will be evaluated using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) by a care provider (either anesthesiologist or nurse).
Time frame: Within the first 48 hours after extubation
Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest
Time frame: Within 48 hours after extubation
Opioid consumption
Time frame: During the 48 hours following extubation
Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable)
Time frame: Within 48 hours after extubation
Time between the end of remifentanil or dexmedetomidine administration and extubation
Time frame: Hour 0 = extubation
Rate of unscheduled admission in intensive care unit
Time frame: Within 48 hours after extubation
Number of postoperative nausea and vomiting (PONV) episodes
Time frame: During the 48 hours following extubation
Hospital length of stay (max 28 days) defined as the number of days after extubation before first hospital discharge
Time frame: Day 28
Number of bradycardia, hypotension and hypertension events during surgery and number of rescue medications during surgery
Bradycardia is defined as the number of episodes with atropine administration. Hypotension is defined as mean arterial blood pressure \< 65 mmHg. Hypertension is defined as mean arterial blood pressure \> 90 mmHg.
Time frame: During surgery (maximum duration of 7 hours)
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