Clinical trial NCT03912740: Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia
Official title: Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Anesthesia
Opioid Use
Perioperative/Postoperative Complications
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Saint-Pierre University Hospital
First posted: 2019-04-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

- American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours

Exclusion Criteria:

* ASA score \>2
* Preoperative organ dysfunction
* Patients with non-regular cardiac rhythm
* Implanted pacemakers
* Emergent surgery
* Pregnancy or lactation
* Allergy or intolerance to any of the study drugs
* Participation in another interventional study
* Patient refusal

Primary outcomes:
measure: Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
timeFrame: 6 hours
Secondary outcomes:
measure: Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic
timeFrame: 6 hours
measure: Use of vasoactive drugs
timeFrame: 6 hours
measure: Use of hypotensive drugs
timeFrame: 6 hours
measure: Net fluid balance
timeFrame: 6 hours
measure: Time to extubation
timeFrame: 6 hours
measure: Number of patients with intraoperative hypotension
timeFrame: 6 hours
measure: Number of patients with intraoperative hypertension
timeFrame: 6 hours
measure: Number of patients with hemodynamic instability
timeFrame: 6 hours
measure: Intraoperative heart rate
timeFrame: 6 hours
measure: Intraoperative blood pressure
timeFrame: 6 hours
measure: Intraoperative Nol-Index
timeFrame: 6 hours
measure: Intraoperative remifentanil target cite concentration
timeFrame: 6 hours
measure: Postoperative morphine consumption
timeFrame: 24 hours
measure: Number of patients with postoperative opioid-related side effect (composite and individual complications)
timeFrame: 72 hours
measure: PACU length of stay (LOS)
timeFrame: 48 hours
measure: Hospital LOS
timeFrame: 28 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Université Libre de Bruxelles
name: Sean Coeckelenbergh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coeckelenbergh S, Doria S, Patricio D, Perrin L, Engelman E, Rodriguez A, Di Marco L, Van Obbergh L, Estebe JP, Barvais L, Kapessidou P. Effect of dexmedetomidine on Nociception Level Index-guided remifentanil antinociception: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):524-533. doi: 10.1097/EJA.0000000000001402.