Dexmedetomidine, Laparoscopic Abdominal Surgery, Remifentanil, Remifentanil Consumption, Total Intravenous Anesthesia
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGPlacebo
Saline will be used instead of dexmedetomidine
Sponsors
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil consumption expressed in mcg.kg-1.h-1 | From induction of anesthesia to end of surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative dose of vasopressors | From induction of anesthesia to end of surgery | Compare the intraoperative requirements of norepinephrine, ephedrine, glycopyrrolate and atropine. |
| intraoperative NOL index | From intubation to end of surgery | compare the percentage of time during the intraoperative period for which the NOL index will be above the pain threshold of 25 |
| Time for extubation (in minutes) | From end of surgery to extubation | Compare the time for extubation |
| Total intraoperative propofol consumption (mg.kg-1.h-1) | From induction of anesthesia to end of surgery | Compare the total intraoperative propofol consumption during anesthesia, to maintien BIS values between 40-60 |
| Mean intraoperative blood pressure | From induction of anesthesia to end of surgery | Compare intraoperative blood pressure in both groups (mmHg) |
| Number of intraoperative episodes of high/low blood pressure | From induction of anesthesia to end of surgery | 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 |
| Number of episodes of intraoperative tachy-/bradycardia | From induction of anesthesia to end of surgery | Compare episodes of tachycardia (defined as \> 100 bpm) and episodes of bradycardia (defined as \< 45 bpm) between both groups |
| Pain scores using visual analogue scale (VAS) in PACU | From PACU admission to discharge from PACU (Aldrete Score >=9 / 10) | Compare pain scores using VAS in PACU |
| Adverse events in PACU | From PACU admission to discharge from PACU (Aldrete Score >=9 / 10) | Compare adverse events in PACU: hypotension, bradycardia and post-operative nausea and vomiting (PONV) |
| Lenght of stay in PACU (in minutes) | From PACU admission to discharge | Compare total time for readiness for discharge from PACU between groups assessed by recovery scores (Aldrete's modified score and Maisonneuve-Rosemont PACU score) |
| Pain scores using numeric rating scale (NRS) 24h post-op | post-op day 1 | Compare pain score between both groups 24h post-op |
| Quality of recovery (QoR) index 24h post-op | post-op day 1 | Compare Quality of recovery (QoR) index 24h post-op |
| Mean intraoperative heart rate | From induction of anesthesia to end of surgery | Compare intraoperative heart rate in both groups (beats per minute) |
| Morphine equivalent consumption in the post anesthesia care unit (PACU) | From PACU admission to discharge from PACU (Aldrete Score >=9 / 10) | Compare total amount of morphine equivalent given in the post anesthesia care unit (mesured in mg) |
Countries
Canada
Contacts
Primary ContactOlivier Verdonck
Backup ContactNadia Godin
Outcome results
None listed