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NCT Number: NCT06684197

The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

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.

Placebo

Drug

Saline will be used instead of dexmedetomidine

Primary outcomes

  1. Remifentanil consumption expressed in mcg.kg-1.h-1

    Time frame: 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 outcomes

  1. Total intraoperative propofol consumption (mg.kg-1.h-1)

    Time frame: From induction of anesthesia to end of surgery

    Compare the total intraoperative propofol consumption during anesthesia, to maintien BIS values between 40-60

  2. Mean intraoperative blood pressure

    Time frame: From induction of anesthesia to end of surgery

    Compare intraoperative blood pressure in both groups (mmHg)

  3. Number of intraoperative episodes of high/low blood pressure

    Time frame: 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

  4. Number of episodes of intraoperative tachy-/bradycardia

    Time frame: 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

  5. Total intraoperative dose of vasopressors

    Time frame: From induction of anesthesia to end of surgery

    Compare the intraoperative requirements of norepinephrine, ephedrine, glycopyrrolate and atropine.

  6. intraoperative NOL index

    Time frame: 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

  7. Time for extubation (in minutes)

    Time frame: From end of surgery to extubation

    Compare the time for extubation

  8. Morphine equivalent consumption in the post anesthesia care unit (PACU)

    Time frame: 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)

  9. Pain scores using visual analogue scale (VAS) in PACU

    Time frame: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)

    Compare pain scores using VAS in PACU

  10. Adverse events in PACU

    Time frame: 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)

  11. Lenght of stay in PACU (in minutes)

    Time frame: 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)

  12. Pain scores using numeric rating scale (NRS) 24h post-op

    Time frame: post-op day 1

    Compare pain score between both groups 24h post-op

  13. Quality of recovery (QoR) index 24h post-op

    Time frame: post-op day 1

    Compare Quality of recovery (QoR) index 24h post-op

  14. Mean intraoperative heart rate

    Time frame: From induction of anesthesia to end of surgery

    Compare intraoperative heart rate in both groups (beats per minute)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Godin

CONTACT

[email protected]

+15142523400 ext. 3193

Olivier Verdonck

CONTACT

[email protected]

+15142523426

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial

Acronym: DEXREM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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