Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03166644 |
| Other study ID # |
CHU-335 |
| Secondary ID |
2016-001603-23 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2017 |
| Est. completion date |
January 20, 2019 |
Study information
| Verified date |
August 2019 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To determine whether a treatment strategy targeting an individualized sufentanil
administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of
sufentanil during major abdominal surgery, as compared with standard practice.
Description:
Postoperative respiratory complications are the second most frequent complications after
surgery, and a major burden in health care. Postoperative hypoxemia, which is one of the most
meaningful factors associated with poor patient outcomes, is common after general anesthesia
with rates as high as 30-50% in patients after abdominal surgery, even among those undergoing
uneventful procedures.
Risk factors for early postoperative hypoxemia, whether modifiable or not, are mainly related
to the patient condition, the surgical procedure and the intraoperative anesthesia management
strategy, especially the detrimental effects resulting from potential residual effects of
anesthetic agents. There is, to date, only limited data on the incidence of postoperative
hypoxemia resulting from excessive intraoperative opioid administration.
The Analgesia Nociception Index (ANI) is a unit-less index ranging from 0 to 100 calculated
from the instantaneous wavelet transform analysis of heart rate variability, which indirectly
reflects the parasympathetic tone, with higher ANI values indicating a prominent
parasympathetic tone. ANI is sensitive to nociception stimuli and has recently been proposed
to evaluate the analgesia/nociception equilibrium. The few interventional studies that have
investigated the ability of a protocol-driven intraoperative analgesia procedure to reduce
postoperative pain have used mixed results. One recent observational study showed that
ANI-guided remifentanil administration during vascular surgery resulted in low opioid
consumption and low postoperative pain rates. In addition, to our knowledge, no study has
investigated whether ANI monitoring can be used to improve postoperative outcome.
Accordingly, to determine the impact of an ANI-guided individualized opioids administration
on postoperative outcomes, a large multicenter randomized controlled trial is needed.
However, before such a trial can take place, it is necessary to determine the feasibility in
potential participating sites of successfully reducing intraoperative opioid consumption
while reducing postoperative pain.
The purpose of this study was to examine the feasibility of undertaking such a trial. Our
primary hypothesis is that individualizing sufentanil administration to target ANI values
between 50 and 70 during major abdominal surgery could reduce the intraoperative dose of
sufentanil, as compared with standard practice.
