Postoperative and Opioid Free Anesthesia

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2019-06-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Opioid-free anesthesia

Control

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Opioid anesthesia

Interventions

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Dexmedetomidine

Opioid-free anesthesia

Intervention Type DRUG

Remifentanil

Opioid anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing a scheduled major or intermediate non-cardiac surgery,
* Benefiting from the health insurance system,
* Having signed an informed consent.

Exclusion Criteria

* Pregnant or breast feeding women,
* Allergy to dexmedetomidine or one of its excipients,
* Allergy to one of the drugs used for anesthesia or one of their excipients,
* Urgent surgery,
* Intracranial surgery,
* Transplant surgery or transplanted patients,
* Surgery with planned regional anesthesia,
* Outpatient surgery,
* Atrioventricular block, intraventricular or sinoatrial block,
* Treatment by chronic betablockers and HR \< 50 bpm,
* Heart failure with LVEF \< 40%,
* Adam-Stokes syndrome,
* Epilepsy or seizures,
* Uncontrolled hypotension,
* Acute cerebral pathology,
* Obstructive sleep apnea syndrome,
* Severe hepatic insufficiency (Prothrombin Ratio \< 15%),
* Patients in whom the CAM-ICU cannot be performed (deaf patients for example)
* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No