Status:
TERMINATED
Postoperative and Opioid Free Anesthesia
Lead Sponsor:
Rennes University Hospital
Conditions:
Anesthesia
Opioid-Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 st...
Eligibility Criteria
Inclusion
- Undergoing a scheduled major or intermediate non-cardiac surgery,
- Benefiting from the health insurance system,
- Having signed an informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT03316339
Start Date
November 29 2017
End Date
June 19 2019
Last Update
October 18 2019
Active Locations (11)
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1
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
2
Beaujon Hospital
Clichy, France
3
Lille University Hospital
Lille, France
4
Metz-Thionville Hospital
Metz, France