The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Placebo.
- Who it may be relevant to
- Registry conditions: Dexmedetomidine, Total Intravenous Anesthesia, Remifentanil Consumption, Remifentanil. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial
Overview
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.
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.
Interventions
- Drug Dexmedetomidine
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. - Drug Placebo
Saline will be used instead of dexmedetomidine
Primary outcome measures
- Remifentanil consumption expressed in mcg.kg-1.h-1 [Time frame: From induction of anesthesia to end of surgery]
Secondary outcome measures (12)
- Total intraoperative propofol consumption (mg.kg-1.h-1) [Time frame: From induction of anesthesia to end of surgery]
- Mean intraoperative blood pressure [Time frame: From induction of anesthesia to end of surgery]
- Number of intraoperative episodes of high/low blood pressure [Time frame: From induction of anesthesia to end of surgery]
- Number of episodes of intraoperative tachy-/bradycardia [Time frame: From induction of anesthesia to end of surgery]
- Total intraoperative dose of vasopressors [Time frame: From induction of anesthesia to end of surgery]
- intraoperative NOL index [Time frame: From intubation to end of surgery]
- Time for extubation (in minutes) [Time frame: From end of surgery to extubation]
- Morphine equivalent consumption in the post anesthesia care unit (PACU) [Time frame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
- Pain scores using visual analogue scale (VAS) in PACU [Time frame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
- Adverse events in PACU [Time frame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
- Lenght of stay in PACU (in minutes) [Time frame: From PACU admission to discharge]
- Pain scores using numeric rating scale (NRS) 24h post-op [Time frame: post-op day 1]
Eligibility criteria
Inclusion criteria
- ASA 1-3
- Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Hôpital Maisonneuve-Rosemont — Montreal
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. PMID 33259449
Identifiers
NCT: NCT06684197 · CAR 2025-3856