The Impact of a Single Dexmedetomidine Bolus on Intraoperative Sevoflurane Consumption (DEXHALE)

NCT05615194 | Unknown

• 1 other identifier: 2023-3190
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Environment; kgCO2eq

Outcome Measures

Primary Outcomes (1)

• Sevoflurane consumption expressed in mL.kg-1.h-1

  To compare the total sevoflurane consumption when using a dexmedetomidine single bolus (group D) of 0.6 mcg.kg-1 on 10 minutes during induction versus placebo (group C). This will be expressed in mL.kg-1.h-1 of surgery.

  From intubation to end of surgery

Secondary Outcomes (10)

• Total intra-operative remifentanil consumption (in mcg.kg-1)

  From intubation to end of surgery

• Percentage of time during the intraoperative period for which the NOL index will be above the pain threshold of 25 (in % of surgical time)

  From intubation to end of surgery

• Total amount of hydromorphone given IV in PACU (in mg)

  From PACU admission to discharge

• Intra-operative and postanesthesia care unit (PACU) doses of vasopressors

  From intubation to PACU discharge

• Mean end tidal sevoflurane (in %) and MAC needed to maintain the BIS index (Medtronic, Canada) between 40 and 60

  From intubation to end of surgery

Study Arms (2)

Placebo

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 over 10 minutes during induction of general anesthesia

Drug: Placebo

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

0.6 mcg/kg in infusion over 10 minutes

Also known as: Precedex, Dexmedetomidine Hydrochloride, DIN : 02339366

Dexmedetomidine

Placebo DRUG

Volume equivalent in infusion over 10 minutes

Also known as: Normal Saline, NaCl 0.9%

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient, the anesthesiologist in charge, the surgeon, the PACU staff and the research team evaluating the patient in PACU will be blinded to the randomization group. The syringe containing the dexmedetomidine or the placebo will be prepared by an anesthesiologist or a pharmacist external to the study and identified by a unique number so that the patient's group can be identified if needed. Both solutions are translucent and total volume to be administered on 10 minutes during induction will be of equal volume.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Deputy chief of the Department of Anesthesiology of Maisonneuve-Rosemont Hospital, University of Montreal(UDeM)

Model Details: Patients will be 1:1 randomly assign to one of the two following groups: dexmedetomidine 0.6 mcg.kg-1 (group D) or a saline placebo of equivalent volume (group C) to be administered on 10 minutes during induction. The patient presenting all the inclusion criteria and no exclusion criteria for this study will be approached by the anesthesia research team. They will provide explanations on the study as well as a consent form to the patient for him to have time to read it before the surgery. The risk of serious and unexpected adverse reactions to dexmedetomidine will also be disclosed to the patient before his agreement to participate to the study. After his approval, the patient will sign the consent and will be randomized.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: December 5, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CA (1)