DexmedetomidineDEXREMNCT06684197
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
A study testing Dexmedetomidine in people with Dexmedetomidine and Total Intravenous Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Total Intravenous Anesthesia, Remifentanil Consumption
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2025to Nov 2026
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.
Who cannot join
- Patient refusal
- Chronic use of opioids
- Allergy to medication used in the trial
- Pregnant or breastfeeding women
- Contraindications to dexmedetomidine (Bradycardia, arrythmia or pace- maker, severe ventricular dysfunction)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T2M4
Olivier Verdonck, +15142523426, overdonck@gmail.com
Nadia Godin, +15142523400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
About this study
Official title: The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial
Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.
Read the detailed description
Opioids analgesic have been used for intraoperative pain management for decades. They are the gold standard for pain relief due to their high efficacy. However, the short- and long-term adverse effects of opioids motivate anesthesia teams to explore opioid sparing strategies employing a combination of analgesics and adjuvants via continuous infusions. Opioid tolerance and opioid-induced hyperalgesia can lead to dose escalation of prescribed opioids and poor pain control.
Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. Other post-procedure applications such as reduction of cough, agitation and shivering have been described.
Many trials have studied the impact of intraoperative dexmedetomidine on post-operative pain scores, post-operative opioids consumption and common side effects compared with a remifentanil intraoperative infusion. One randomized controlled trial studied the impact of a 30 min dexmedetomidine infusion on intraoperative remifentanil consumption in ASA 1-2 patients undergoing maxillofacial or cervicofacial surgeries. They found a clinically meaningful reduction of 33% of remifentanil consumption at 120 minutes in the dexmedetomidine group. This trial aims to demonstrate a similar reduction when extending to ASA 3 patients undergoing laparoscopic surgery. Furthermore, the investigators aim to evaluate patients' recovery and pain status 24h after the surgery which hasn't been done before in the context of joint dexmedetomidine and remifentanil infusion. The investigators hypothesize that patients of the dexmedetomidine infusion group will require less intraoperative remifentanil to keep the NOL-index into the prespecified range. In the PACU, lower pain score et less opioids requirements are anticipated.
- Conditions
- Dexmedetomidine, Total Intravenous Anesthesia, Remifentanil Consumption, Remifentanil, Laparoscopic Abdominal Surgery
- Being tested
- Dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous dexmedetomidine will be given as a bolus (0.5 μg.kg-1) over 10 minutes. A perfusion of 0.5 mcg.kg-1.h-1 of dexmedetomidine will be programmed and maintained up until the pneumoperitoneum is deflated or up until a total dose of 2.5μg.kg-1 has been administered.
PlaceboDrug
Saline will be used instead of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine 0.5 mcg/kg (adjusted body weight) ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) delivered over 10 minutes during induction of general anesthesia, followed by dexmedetomidine 0.5 mcg.kg-1.h-1 (maximum dose: 2.5mcg.kg-1) Receives: Drug: Dexmedetomidine |
| Placebo - Normal Saline | Placebo comparator | Normal saline in volume equivalent of dexmedetomidine dose according to patient weight ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) so that the full dose is delivered is equivalent to a maximum dose of 2.5mcg.kg-1 of dexemedetomidine Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption expressed in mcg.kg-1.h-1
Compare remifentanil consumption when using an intraoperative dexmedetomidine infusion (bolus of 0.5mcg.kg-1, than infusion of 0.5 mcg.kg-1.h-1, with a maximum dose of 2.5 mcg.kg-1) versus placebo (normal saline)
Measured: From induction of anesthesia to end of surgery
Secondary outcomes (14)
Total intraoperative propofol consumption (mg.kg-1.h-1)
Compare the total intraoperative propofol consumption during anesthesia, to maintien BIS values between 40-60
Measured: From induction of anesthesia to end of surgery
Mean intraoperative blood pressure
Compare intraoperative blood pressure in both groups (mmHg)
Measured: From induction of anesthesia to end of surgery
Number of intraoperative episodes of high/low blood pressure
Compare episodes of high blood pressure (defined as + 20% of patient's baseline) ans episodes of low blood pressure (defined as - 20% of patient's baseline) between both groups
Measured: From induction of anesthesia to end of surgery
Number of episodes of intraoperative tachy-/bradycardia
Compare episodes of tachycardia (defined as > 100 bpm) and episodes of bradycardia (defined as < 45 bpm) between both groups
Measured: From induction of anesthesia to end of surgery
Total intraoperative dose of vasopressors
Compare the intraoperative requirements of norepinephrine, ephedrine, glycopyrrolate and atropine.
Measured: From induction of anesthesia to end of surgery
intraoperative NOL index
compare the percentage of time during the intraoperative period for which the NOL index will be above the pain threshold of 25
Measured: From intubation to end of surgery
Time for extubation (in minutes)
Compare the time for extubation
Measured: From end of surgery to extubation
Morphine equivalent consumption in the post anesthesia care unit (PACU)
Compare total amount of morphine equivalent given in the post anesthesia care unit (mesured in mg)
Measured: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
Pain scores using visual analogue scale (VAS) in PACU
Compare pain scores using VAS in PACU
Measured: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
Adverse events in PACU
Compare adverse events in PACU: hypotension, bradycardia and post-operative nausea and vomiting (PONV)
Measured: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
Lenght of stay in PACU (in minutes)
Compare total time for readiness for discharge from PACU between groups assessed by recovery scores (Aldrete's modified score and Maisonneuve-Rosemont PACU score)
Measured: From PACU admission to discharge
Pain scores using numeric rating scale (NRS) 24h post-op
Compare pain score between both groups 24h post-op
Measured: post-op day 1
Quality of recovery (QoR) index 24h post-op
Compare Quality of recovery (QoR) index 24h post-op
Measured: post-op day 1
Mean intraoperative heart rate
Compare intraoperative heart rate in both groups (beats per minute)
Measured: From induction of anesthesia to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start9 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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 DexmedetomidineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Verdonck, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684197
- Sponsor's protocol ID
- CAR 2025-3856
- Acronym
- DEXREM
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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