Status:
COMPLETED
Ability of Pupillometry to Reduce Sufentanil Consumption in Planned Cardiac Surgery: Randomized, Controlled, Single-center Clinical Superiority Trial
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Patients Undergoing Cardiac Surgery
Patients With Coronary Artery Bypass Surgery With CEC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Com...
Eligibility Criteria
Inclusion
- Person who has given written consent
- Adult patient
- Patient undergoing coronary artery bypass surgery with CEC, with or without valve surgery, by sternotomy.
- ASA \<4.
Exclusion
- Person not affiliated to the national health insurance system
- Person subject to legal protection (curatorship, guardianship)
- Person who has been deemed mentally incompetent
- Pregnant, parturient or breastfeeding woman
- Adult unable or unwilling to provide consent
- Patient with preoperative cognitive dysfunction (MMS \<13) (APPENDIX 6),
- Patient with morphine intolerance,
- Patient on long-term opioid treatment,
- Emergency surgery,
- Eye disease, corneal injury, or wearing contact lenses, a neurological disease that can influence the pupillary reflex,
- Refusal to participate
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03864016
Start Date
March 20 2019
End Date
October 22 2019
Last Update
January 23 2020
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 2100