Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

NCT03912740 | Completed

• 1 other identifier: P2018/568
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain; Anesthesia; Opioid Use; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

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

  Intraoperative remifentanil consumption

  6 hours

Secondary Outcomes (16)

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

  6 hours

• Use of vasoactive drugs

  6 hours

• Use of hypotensive drugs

  6 hours

• Net fluid balance

  6 hours

• Time to extubation

  6 hours

Study Arms (2)

Remifentanil Analgesia

ACTIVE COMPARATOR

Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride

Drug: sodium chloride; Drug: Remifentanil

Remifentanil and Dexmedetomidine Analgesia

ACTIVE COMPARATOR

Continuous intraoperative analgesia with remifenanil + dexmedetomidine

Drug: Dexmedetomidine; Drug: Remifentanil

Interventions

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.

Also known as: Dexdor

Remifentanil and Dexmedetomidine Analgesia

sodium chloride DRUG

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

Also known as: normal saline 0.9%

Remifentanil Analgesia

Remifentanil DRUG

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

Also known as: Ultiva

Remifentanil Analgesia; Remifentanil and Dexmedetomidine Analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Saint-Pierre University Hospital: collaborator

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33259449 DERIVED

MeSH Terms

Conditions

Nociceptive Pain; Postoperative Complications

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution; Remifentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Sean Coeckelenbergh, M.D.

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: April 11, 2019
• Study Start: April 11, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

BE (1)