Recruiting

Dexmedetomidine

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05615194

Conditions

Inhalation Anesthesia

Dexmedetomidine

Sevoflurane

Laparoscopy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexmedetomidine

Placebo

Study Details

Brief summary:

Sevoflurane is a volatile agent easy to control thanks to the Minimum Alveolar Concentration (MAC) allowing its titration for an optimal depth of anesthesia. Growing biomedical evidence also highlight its anti-inflammatory and antioxidant effects protecting against ischemia-reperfusion injury in cardiac surgery and, potentially, in organ transplant. The estimated annual contribution of inhalational anesthetic agents represents about 0.01% of global CO2 production. Alternatives such as total intravenous anesthesia (TIVA) avoid direct greenhouse emission, but their indirect carbon footprint remains a major problem. For all these reasons, this research aim to find a way to maintain the use of sevoflurane for its clinical benefits while reducing its consumption to limit the environmental consequences. The use of dexmedetomidine could help anesthesiologists to achieve this greener sevoflurane anesthesia. Dexmedetomidine is a potent, highly selective α-2 adrenergic receptor agonist described as a unique sedative with analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether a single bolus of dexmedetomidine (0.6 mcg.kg-1 on 10 minutes during induction) compared to placebo has a clinically significant impact on sevoflurane consumption during laparoscopic elective surgery.

Conditions

Inhalation Anesthesia

Dexmedetomidine

Sevoflurane

Laparoscopy

Study ID

NCT05615194

Start date

Dec 5, 2022

Status verified date

Feb, 2023

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ASA 1-3 patients
  • Undergoing laparoscopic surgery of duration time expected under 120 minutes using general anesthesia with sevoflurane
  • Fully consented
  • Age > 18yo
  • No allergy to one of the medications used in this study.

Exclusion Criteria:

  • History of severe coronary artery disease; ventricular dysfunction, serious cardiac arrhythmia (including atrial fibrillation and high-grade atrioventricular block)
  • Moderate to severe renal or hepatic dysfunction
  • Allergy to any drug used in the study protocol
  • Refusal of the patient for participation in the study
  • History of severe PONV

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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 over 10 minutes during induction of general anesthesia

active comparator: Dexmedetomidine

Dexmedetomidine 0.6 mcg/kg (adjusted body weight) ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) so that the full dose is delivered over 10 minutes during induction of general anesthesia

Interventions

Dexmedetomidine

0.6 mcg/kg in infusion over 10 minutes

Placebo

Volume equivalent in infusion over 10 minutes

Primary outcome measure

  • Sevoflurane consumption expressed in mL.kg-1.h-1 [ Time Frame: From intubation to end of surgery ]

Central Contacts and Locations

Locations

Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Recruiting

Montréal, Quebec, Canada, H1T2M4

Contacts

Principal Investigator:

Olivier Verdonck, MD

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 15, 2023

Last verified

Feb, 2023

Keywords

  • Environment
  • kgCO2eq

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2023-02-15.