Surgical Procedure, Unspecified Clinical Trial
— ANI-LOOPOfficial title:
Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia
Verified date | November 2022 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.
Status | Completed |
Enrollment | 52 |
Est. completion date | November 22, 2022 |
Est. primary completion date | June 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille Exclusion Criteria: - BMI outside [17 - 35 kg/m2] - pregnancy or breast feeding women - non sinus cardiac rhythm - documented dysautonomia - complicated diabetes mellitus - known allergy to a drug used in the clinical trial |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro, CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | normalized remifentanil administration | ratio of total amount of administered remifentanil with body weight and duration of administration | During the surgery, an average Three hours and a half | |
Secondary | hemodynamic reactivity or bradycardia or hypotension | relative amount of time during which heart rate or SBP exceed 120% of baseline, or heart rate drops below 40/min, or SBP drops below 75 mmHg. | During the surgery, an average Three hours and a half | |
Secondary | total administered ephedrine | total amount of ephedrine administered during general anesthesia | duration of general anesthesia | |
Secondary | Analgesia Nociception Index (ANI) | relative amount of time spent with ANIi in the [0-50], [50-70] and [70-100] windows. Same with ANIm | During the surgery, an average Three hours and a half | |
Secondary | Bispectral Index (BIS) | relative amount of time spent with BIS in the [0-40], [40-60] and [60-100] windows. | During the surgery, an average Three hours and a half | |
Secondary | Change antinociception/nociception balance status | composite measure: heart rate, blood pressure, ANIi, ANIm, end-tidal CO2, PeakPressure | 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception | |
Secondary | Pain in PACU | Visual Analog Scale every 15 min in PACU The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (0, 10). | During the first two postoperative hours | |
Secondary | morphine in PACU | Total amount of administered morphine during PACU stay | During the first two postoperative hours | |
Secondary | ketamine in PACU | Total amount of administered ketamine during PACU stay | During the first two postoperative hours | |
Secondary | nausea/vomiting in PACU | reported number of nausea/vomiting during PACU stay | During the first two postoperative hours | |
Secondary | remi target changes | total number of target changes during general anesthesia | During the surgery, an average Three hours and a half | |
Secondary | propofol target changes | total number of target changes during general anesthesia | During the surgery, an average Three hours and a half | |
Secondary | normalized propofol administration | ratio of total amount of propofol administered with body weight and duration of general anesthesia | During the surgery, an average Three hours and a half | |
Secondary | ANI-REMI-loop switch to manual | number of interventions on ANI-REMI-loop device: switch to manual | During the surgery, an average Three hours and a half |
Status | Clinical Trial | Phase | |
---|---|---|---|
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