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Postoperative and Opioid Free Anesthesia
POFA
Effect of Opioid-free Anesthesia on Postoperative Opioid-related Adverse Events After Major or Intermediate Non-cardiac Surgery: a Multicenter Prospective Randomized Controlled Study
1 other identifier
interventional
316
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2017
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedOctober 18, 2019
October 1, 2019
1.2 years
October 13, 2017
October 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Within the first 48 hours after extubation
Secondary Outcomes (8)
Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest
Within 48 hours after extubation
Opioid consumption
During the 48 hours following extubation
Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable)
Within 48 hours after extubation
Time between the end of remifentanil or dexmedetomidine administration and extubation
Hour 0 = extubation
Rate of unscheduled admission in intensive care unit
Within 48 hours after extubation
- +3 more secondary outcomes
Study Arms (2)
Dexmedetomidine
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Undergoing a scheduled major or intermediate non-cardiac surgery,
- Benefiting from the health insurance system,
- Having signed an informed consent.
You may not qualify if:
- 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,
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Toulouse University Hospital
Toulouse, France
Related Publications (1)
Beloeil H, Laviolle B, Menard C, Paugam-Burtz C, Garot M, Asehnoune K, Minville V, Cuvillon P, Oger S, Nadaud J, Lecoeur S, Chanques G, Futier E; SFAR research network. POFA trial study protocol: a multicentre, double-blind, randomised, controlled clinical trial comparing opioid-free versus opioid anaesthesia on postoperative opioid-related adverse events after major or intermediate non-cardiac surgery. BMJ Open. 2018 Jun 30;8(6):e020873. doi: 10.1136/bmjopen-2017-020873.
PMID: 29961015DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène BELOEIL
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 20, 2017
Study Start
November 29, 2017
Primary Completion
January 29, 2019
Study Completion
June 19, 2019
Last Updated
October 18, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share