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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
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.
Saline will be used instead of dexmedetomidine
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
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)
Time frame: From induction of anesthesia to end of surgery
Total intraoperative propofol consumption (mg.kg-1.h-1)
Compare the total intraoperative propofol consumption during anesthesia, to maintien BIS values between 40-60
Time frame: From induction of anesthesia to end of surgery
Mean intraoperative blood pressure
Compare intraoperative blood pressure in both groups (mmHg)
Time frame: 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
Time frame: 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
Time frame: From induction of anesthesia to end of surgery
Total intraoperative dose of vasopressors
Compare the intraoperative requirements of norepinephrine, ephedrine, glycopyrrolate and atropine.
Time frame: 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
Time frame: From intubation to end of surgery
Time for extubation (in minutes)
Compare the time for extubation
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: From PACU admission to discharge
Pain scores using numeric rating scale (NRS) 24h post-op
Compare pain score between both groups 24h post-op
Time frame: post-op day 1
Quality of recovery (QoR) index 24h post-op
Compare Quality of recovery (QoR) index 24h post-op
Time frame: post-op day 1
Mean intraoperative heart rate
Compare intraoperative heart rate in both groups (beats per minute)
Time frame: From induction of anesthesia to end of surgery
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