Recruiting

Dexmedetomidine

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06684197

Conditions

Dexmedetomidine

Total Intravenous Anesthesia

Remifentanil Consumption

Remifentanil

Laparoscopic Abdominal Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Dexmedetomidine

Placebo

Study Details

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.

Conditions

Dexmedetomidine

Total Intravenous Anesthesia

Remifentanil Consumption

Remifentanil

Laparoscopic Abdominal Surgery

Study ID

NCT06684197

Start date

May 9, 2025

Status verified date

Oct, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Dexmedetomidine

Dexmedetomidine 0.5 mcg/kg (adjusted body weight) ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) delivered over 10 minutes during induction of general anesthesia, followed by dexmedetomidine 0.5 mcg.kg-1.h-1 (maximum dose: 2.5mcg.kg-1)

placebo comparator: Placebo - Normal Saline

Normal saline in volume equivalent of dexmedetomidine dose according to patient weight ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) so that the full dose is delivered is equivalent to a maximum dose of 2.5mcg.kg-1 of dexemedetomidine

Interventions

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.

Placebo

Saline will be used instead of dexmedetomidine

Primary outcome measure

  • Remifentanil consumption expressed in mcg.kg-1.h-1 [ Time Frame: From induction of anesthesia to end of surgery ]

Central Contacts and Locations

Central contacts

Olivier Verdonck

+15142523426overdonck@gmail.com

Nadia Godin

+15142523400ngodin.hmr@ssss.gouv.qc.ca

Locations

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Olivier Verdonck

+15142523426overdonck@gmail.com

Nadia Godin

+15142523400ngodin.hmr@ssss.gouv.qc.ca

Principal Investigator:

Olivier Verdonck

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.