Trial | NCT03912740  Report issue

Title

Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia
Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    58
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 Started
Apr 11
2019
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Last Update
Apr 03
2020

Drug Dexmedetomidine

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.

  • Other names: Dexdor

Drug sodium chloride

Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)

  • Other names: normal saline 0.9%

Drug Remifentanil

Both groups will have remifentanil analgesia guided by the Nol-Index

  • Other names: Ultiva

Remifentanil Analgesia Active Comparator

Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride

Remifentanil and Dexmedetomidine Analgesia Active Comparator

Continuous intraoperative analgesia with remifenanil + dexmedetomidine

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
No Results Posted