Nociceptive PainNCT03912740
Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia
A study testing Dexmedetomidine, sodium chloride and Remifentanil in people with Nociceptive Pain and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nociceptive Pain, Anesthesia, Opioid Use
- What is being tested?
- Dexmedetomidine, sodium chloride and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours
Who cannot join
- ASA score >2
- Preoperative organ dysfunction
- Patients with non-regular cardiac rhythm
- Implanted pacemakers
- Emergent surgery
- Pregnancy or lactation
Show all 9Show fewer
- Allergy or intolerance to any of the study drugs
- Participation in another interventional study
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Dexmedetomidine, sodium chloride, Remifentanil
- Medical subject headings
- Nociceptive Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
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.
sodium chlorideDrug
Also called normal saline 0.9%
Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)
RemifentanilDrug
Also called Ultiva
Both groups will have remifentanil analgesia guided by the Nol-Index
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil Analgesia | Active comparator | Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride Receives: Drug: sodium chloride; Drug: Remifentanil |
| Remifentanil and Dexmedetomidine Analgesia | Active comparator | Continuous intraoperative analgesia with remifenanil + dexmedetomidine Receives: Drug: Dexmedetomidine; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
Intraoperative remifentanil consumption
Measured: 6 hours
Secondary outcomes (16)
Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic
Intraoperative propofol consumption
Measured: 6 hours
Use of vasoactive drugs
Use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline)
Measured: 6 hours
Use of hypotensive drugs
Use and amount of hypotensive drugs used (nicardipine/esmolol)
Measured: 6 hours
Net fluid balance
Sum of in (infused fluids) and out (net blood loss, diuresis, other losses)
Measured: 6 hours
Time to extubation
Time from end of surgery to extubation of patient
Measured: 6 hours
Number of patients with intraoperative hypotension
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).
Measured: 6 hours
Number of patients with intraoperative hypertension
Intraoperative MAP≥100 or surgical need to decrease blood pressure
Measured: 6 hours
Number of patients with hemodynamic instability
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).
Measured: 6 hours
Intraoperative heart rate
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)
Measured: 6 hours
Intraoperative blood pressure
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)
Measured: 6 hours
Intraoperative Nol-Index
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)
Measured: 6 hours
Intraoperative remifentanil target cite concentration
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)
Measured: 6 hours
Postoperative morphine consumption
mg of morphine administered postoperatively
Measured: 24 hours
Number of patients with postoperative opioid-related side effect (composite and individual complications)
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.
Measured: 72 hours
PACU length of stay (LOS)
hours spent at PACU
Measured: 48 hours
Hospital LOS
days spents hospitalized
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start11 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Pierre University Hospital
- Responsible party
- Sponsor
- Investigators
- Sean Coeckelenbergh, M.D., Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912740
- Sponsor's protocol ID
- P2018/568
- Status last verified
- Apr 2020
- First submitted
- 25 Feb 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33259449
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03912740
- Acronym / sponsor ID
- P2018/568
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Saint-Pierre University Hospital
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil Analgesia | Active comparator | Drug: sodium chloride, Drug: RemifentanilContinuous intraoperative analgesia with remifenanil + 0.9% sodium chloride |
| Remifentanil and Dexmedetomidine Analgesia | Active comparator | Drug: Dexmedetomidine, Drug: RemifentanilContinuous intraoperative analgesia with remifenanil + dexmedetomidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours
Key exclusion criteria (9 listed)
- ASA score >2
- Preoperative organ dysfunction
- Patients with non-regular cardiac rhythm
- Implanted pacemakers
- Emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: DexdorPatients 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. | Drug | Remifentanil and Dexmedetomidine Analgesia |
| sodium chlorideAlso: normal saline 0.9%Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate) | Drug | Remifentanil Analgesia |
| RemifentanilAlso: UltivaBoth groups will have remifentanil analgesia guided by the Nol-Index | Drug | Remifentanil Analgesia, Remifentanil and Dexmedetomidine Analgesia |
Primary outcome
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
Time frame: 6 hours
Intraoperative remifentanil consumption
16 secondary outcomes
Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic
Time frame: 6 hours
Use of vasoactive drugs
Time frame: 6 hours
Use of hypotensive drugs
Time frame: 6 hours
Net fluid balance
Time frame: 6 hours
Time to extubation
Time frame: 6 hours
Number of patients with intraoperative hypotension
Time frame: 6 hours
Number of patients with intraoperative hypertension
Time frame: 6 hours
Number of patients with hemodynamic instability
Time frame: 6 hours
Intraoperative heart rate
Time frame: 6 hours
Intraoperative blood pressure
Time frame: 6 hours
Intraoperative Nol-Index
Time frame: 6 hours
Intraoperative remifentanil target cite concentration
Time frame: 6 hours
Postoperative morphine consumption
Time frame: 24 hours
Number of patients with postoperative opioid-related side effect (composite and individual complications)
Time frame: 72 hours
PACU length of stay (LOS)
Time frame: 48 hours
Hospital LOS
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 33259449Coeckelenbergh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Coeckelenbergh, M.D. principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, sodium chloride and Remifentanil in people with Nociceptive Pain and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03912740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.