The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption

NCT06684197 | Not Yet Recruiting

• 1 other identifier: CAR 2025-3856
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  From induction of anesthesia to end of surgery

Secondary Outcomes (14)

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

  From induction of anesthesia to end of surgery

• Mean intraoperative blood pressure

  From induction of anesthesia to end of surgery

• Number of intraoperative episodes of high/low blood pressure

  From induction of anesthesia to end of surgery

• Number of episodes of intraoperative tachy-/bradycardia

  From induction of anesthesia to end of surgery

• Total intraoperative dose of vasopressors

  From induction of anesthesia to end of surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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)

Drug: Dexmedetomidine

Placebo - Normal Saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Dexmedetomidine

Placebo DRUG

Saline will be used instead of dexmedetomidine

Placebo - Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-3
• Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 33259449 RESULT

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Olivier Verdonck

CONTACT

+15142523426; overdonck@gmail.com

Nadia Godin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Clinical Assistant Professor, Head of Department of Anesthesiology and Pain Medecine

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CA (1)