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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Patients in the dexmedetomidine-remifentanil group will receive an infusion of 0.6 mcg/kg in half an hour followed by an infusion of 0.6 mcg/kg/hour.
Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)
Both groups will have remifentanil analgesia guided by the Nol-Index
Erasme University Hospital
Brussels, Belgium
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
Intraoperative remifentanil consumption
Time frame: 6 hours
Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic
Intraoperative propofol consumption
Time frame: 6 hours
Use of vasoactive drugs
Use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline)
Time frame: 6 hours
Use of hypotensive drugs
Use and amount of hypotensive drugs used (nicardipine/esmolol)
Time frame: 6 hours
Net fluid balance
Sum of in (infused fluids) and out (net blood loss, diuresis, other losses)
Time frame: 6 hours
Time to extubation
Time from end of surgery to extubation of patient
Time frame: 6 hours
Number of patients with intraoperative hypotension
Intraoperative MAP (mean arterial pressure) \<65 mmHg\* * Patients that have chronic hypertension or that are 65 years of age or older will have a MAP threshold of 75mmHg (and not 65mmHg).
Time frame: 6 hours
Number of patients with intraoperative hypertension
Intraoperative MAP≥100 or surgical need to decrease blood pressure
Time frame: 6 hours
Number of patients with hemodynamic instability
MAP\<65 mmHg\*, HR\<45, MAP≥100, HR\>90 \* Patients that have chronic hypertension or that are 65 years of age or older will have a MAP threshold of 75mmHg for hypotension (and not 65mmHg).
Time frame: 6 hours
Intraoperative heart rate
Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Time frame: 6 hours
Intraoperative blood pressure
Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Time frame: 6 hours
Intraoperative Nol-Index
Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Time frame: 6 hours
Intraoperative remifentanil target cite concentration
Measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia)
Time frame: 6 hours
Postoperative morphine consumption
mg of morphine administered postoperatively
Time frame: 24 hours
Number of patients with postoperative opioid-related side effect (composite and individual complications)
Post-operative nausea or vomiting within the first 24 h, postoperative hypoxemia (need within 24h postop to have supplemental oxygen (to maintain sat \>94%), and pruritus.
Time frame: 72 hours
PACU length of stay (LOS)
hours spent at PACU
Time frame: 48 hours
Hospital LOS
days spents hospitalized
Time frame: 28 days
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