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Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

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ClinicalTrials.gov Identifier: NCT03912740
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Saint-Pierre University Hospital
Information provided by (Responsible Party):
Erasme University Hospital

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.


Condition or disease Intervention/treatment Phase
Nociceptive Pain Anesthesia Opioid Use Perioperative/Postoperative Complications Drug: Dexmedetomidine Drug: sodium chloride Drug: Remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil Analgesia
Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride
Drug: sodium chloride
Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)
Other Name: normal saline 0.9%

Drug: Remifentanil
Both groups will have remifentanil analgesia guided by the Nol-Index
Other Name: Ultiva

Active Comparator: Remifentanil and Dexmedetomidine Analgesia
Continuous intraoperative analgesia with remifenanil + dexmedetomidine
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 Name: Dexdor

Drug: Remifentanil
Both groups will have remifentanil analgesia guided by the Nol-Index
Other Name: Ultiva




Primary Outcome Measures :
  1. Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic [ Time Frame: 6 hours ]
    Intraoperative remifentanil consumption


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912740


Contacts
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Contact: Sean Coeckelenbergh, M.D. +322 535 35 93 secoecke@ulb.ac.be
Contact: Luc Barvais, M.D., Ph.D. +322 555 39 19 luc.barvais@erasme.ulb.ac.be

Locations
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Belgium
Erasme University Hospital Recruiting
Bruxelles, Belgium, 1070
Contact: Luc Barvais, PhD       Luc.Barvais@erasme.ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital
Saint-Pierre University Hospital
Investigators
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Principal Investigator: Sean Coeckelenbergh, M.D. Université Libre de Bruxelles

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03912740     History of Changes
Other Study ID Numbers: P2018/568
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Nociceptive Pain
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics