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NCT Number: NCT03912740

Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

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.

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Key information

Conditions

Nociceptive Pain Anesthesia Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Sodium Chloride

Drug

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%

Remifentanil

Drug

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

Other names: Ultiva

Primary outcomes

  1. Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic

    Time frame: 6 hours

    Intraoperative remifentanil consumption

Secondary outcomes

  1. Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic

    Time frame: 6 hours

    Intraoperative propofol consumption

  2. Use of vasoactive drugs

    Time frame: 6 hours

    Use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline)

  3. Use of hypotensive drugs

    Time frame: 6 hours

    Use and amount of hypotensive drugs used (nicardipine/esmolol)

  4. Net fluid balance

    Time frame: 6 hours

    Sum of in (infused fluids) and out (net blood loss, diuresis, other losses)

  5. Time to extubation

    Time frame: 6 hours

    Time from end of surgery to extubation of patient

  6. Number of patients with intraoperative hypotension

    Time frame: 6 hours

    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).

  7. Number of patients with intraoperative hypertension

    Time frame: 6 hours

    Intraoperative MAP≥100 or surgical need to decrease blood pressure

  8. Number of patients with hemodynamic instability

    Time frame: 6 hours

    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).

  9. Intraoperative heart rate

    Time frame: 6 hours

    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)

  10. Intraoperative blood pressure

    Time frame: 6 hours

    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)

  11. Intraoperative Nol-Index

    Time frame: 6 hours

    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)

  12. Intraoperative remifentanil target cite concentration

    Time frame: 6 hours

    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)

  13. Postoperative morphine consumption

    Time frame: 24 hours

    mg of morphine administered postoperatively

  14. Number of patients with postoperative opioid-related side effect (composite and individual complications)

    Time frame: 72 hours

    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.

  15. PACU length of stay (LOS)

    Time frame: 48 hours

    hours spent at PACU

  16. Hospital LOS

    Time frame: 28 days

    days spents hospitalized

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Saint-Pierre University Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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