Anesthesia Clinical Trial
Official title:
Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
Background:
Analgesia remains to this day a challenge for anesthesiologists. Dexmedetomidine, a potent
central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. The
classic analgesic strategy focuses on opioid administration guided by estimated time of
elimination and hemodynamic response (increase in blood pressure and heart rate). This
technique is not sensitive and forces the anesthesiologist to be one step behind nociception,
the patient's unconscious response to pain.
PMD-200 (Medasense, Israel) displays the Nociceptive level (NOL)-Index as marker of
nociception. The NOL-Index ranges from 0 (no nociception) to 100 (intense nociception) and
the recommended analgesic range during surgery is from 10 to 25 (Medasense recommendations).
The goal of this study is to compare two analgesia strategies guided by the NOL Index (range
10-25) using either remifentanil TCI (target controlled infusion) alone or remifentanil TCI
associated with a continuous dexmedetomidine infusion.
Methods:
A total of 100 patients will be included and informed consent will be acquired. This
bi-center study will take place at Erasme University Hospital (primary center) and
Saint-Pierre University Hospital. Patients will be randomized into either two groups:
remifentanil and placebo versus remifentanil and dexmedetomidine. Both groups will be
monitored using the PMD-200 that will guide the analgesic therapy strategy. Investigators and
patients will be blinded to dexmedetomidine and placebo administration. The primary outcome
will be intraoperative remifentanil consumption. Secondary outcomes will include
postoperative opioid administration, opioid associated complications, hemodynamics, and
hospital length of stay.
n/a
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