Clinical trial NCT06684197: The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Official title: The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Total Intravenous Anesthesia
Remifentanil Consumption
Remifentanil
Laparoscopic Abdominal Surgery
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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)

Primary outcomes:
measure: Remifentanil consumption expressed in mcg.kg-1.h-1
timeFrame: From induction of anesthesia to end of surgery
Secondary outcomes:
measure: Total intraoperative propofol consumption (mg.kg-1.h-1)
timeFrame: From induction of anesthesia to end of surgery
measure: Mean intraoperative blood pressure
timeFrame: From induction of anesthesia to end of surgery
measure: Number of intraoperative episodes of high/low blood pressure
timeFrame: From induction of anesthesia to end of surgery
measure: Number of episodes of intraoperative tachy-/bradycardia
timeFrame: From induction of anesthesia to end of surgery
measure: Total intraoperative dose of vasopressors
timeFrame: From induction of anesthesia to end of surgery
measure: intraoperative NOL index
timeFrame: From intubation to end of surgery
measure: Time for extubation (in minutes)
timeFrame: From end of surgery to extubation
measure: Morphine equivalent consumption in the post anesthesia care unit (PACU)
timeFrame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
measure: Pain scores using visual analogue scale (VAS) in PACU
timeFrame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
measure: Adverse events in PACU
timeFrame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)
measure: Lenght of stay in PACU (in minutes)
timeFrame: From PACU admission to discharge
measure: Pain scores using numeric rating scale (NRS) 24h post-op
timeFrame: post-op day 1
measure: Quality of recovery (QoR) index 24h post-op
timeFrame: post-op day 1
measure: Mean intraoperative heart rate
timeFrame: From induction of anesthesia to end of surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
References:
citation: 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.