Postoperative and Opioid Free Anesthesia
Keywords
Abstract
Dates
Last Verified: | 09/30/2019 |
First Submitted: | 10/12/2017 |
Estimated Enrollment Submitted: | 10/18/2017 |
First Posted: | 10/19/2017 |
Last Update Submitted: | 10/15/2019 |
Last Update Posted: | 10/17/2019 |
Actual Study Start Date: | 11/28/2017 |
Estimated Primary Completion Date: | 01/28/2019 |
Estimated Study Completion Date: | 06/18/2019 |
Condition or disease
Intervention/treatment
Drug: Dexmedetomidine
Drug: Control
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Dexmedetomidine | Drug: Dexmedetomidine Opioid-free anesthesia |
Active Comparator: Control | Drug: Control Opioid anesthesia |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | 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. |
Outcome
Primary Outcome Measures
1. Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD). [Within the first 48 hours after extubation]
Secondary Outcome Measures
1. Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest [Within 48 hours after extubation]
2. Opioid consumption [During the 48 hours following extubation]
3. Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable) [Within 48 hours after extubation]
4. Time between the end of remifentanil or dexmedetomidine administration and extubation [Hour 0 = extubation]
5. Rate of unscheduled admission in intensive care unit [Within 48 hours after extubation]
6. Number of postoperative nausea and vomiting (PONV) episodes [During the 48 hours following extubation]
7. Hospital length of stay (max 28 days) defined as the number of days after extubation before first hospital discharge [Day 28]
8. Number of bradycardia, hypotension and hypertension events during surgery and number of rescue medications during surgery [During surgery (maximum duration of 7 hours)]