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Inhalation AnesthesiaNCT05615194

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

A study testing Dexmedetomidine in people with Inhalation Anesthesia and Dexmedetomidine, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteCanada
Study dates
5 Dec 2022to 1 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

    Montreal, Quebec, H1T2M4

Other trials in Canada

About this study

Official title: A Randomized Clinical Study to Assess the Impact of a Single Dexmedetomidine Bolus During Induction of General Anesthesia on Intraoperative Sevoflurane Consumption in Elective Laparoscopic Surgery

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.

Read the detailed description

Inhaled gases have been used since the advent of anesthesia due to their analgesic and dissociative properties. However, these are now part of a growing environmental debate which leads us to reconsider their systematic use for general anesthesia. Sevoflurane is a volatile agent easy to monitor using the Minimal Alveolar Concentration (MAC) facilitating its titration for adequate anesthesia depth. 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. This data can be illustrated as a commercial airliner flying 418 times around the world. Desflurane is gradually abandoned as its greenhouse effect is 25 times more potent than sevoflurane for an equivalent MAC and fresh gas flow. As low-flow inhalational techniques and scavenging technologies become the standard of practice, anesthesiologists still cannot prevent the gas to be released in the atmosphere .

Alternatives such as total intravenous anesthesia (TIVA) avoid direct greenhouse emission, but their indirect carbon footprint remains a major problem. Propofol has a high potential for bioaccumulation. It has high mobility in soil, resists degradation in aquatic environment and concentrates in adipose tissue of aquatic organism. To control its toxicity, destruction should be done by incineration over 1000°C. Unfortunately, studies prove that 32-49% of dispensed propofol is waisted and is mostly disposed unproperly.

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 us 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. Currently approved for sedation, this molecule shows many advantages compared to hypnotic drugs such as propofol. Although still under investigation, dexmedetomidine would possibly have a lower hazard environmental score. The use of dexmedetomidine also shows promising results regarding the reduction of emergence cough and agitation. Decrease in pain and post-operative nausea and vomiting (PONV) are other benefits of dexmedetomidine providing conditions to promote enhanced recovery after surgery (ERAS).

Many investigations have studied impacts of dexmedetomidine as an adjuvant to general anesthesia for its opioid sparing capacity, and hemodynamics response during laparoscopic surgeries. Fewer research specifically wondered about sevoflurane dispense outcome. Moreover, they don't reflect the anesthesia practice of North America and their sample sizes are low.

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. Opioid requirement, need for vasopressors, post-operative events (PONV, shivering, critical respiratory event) and time for readiness for Post-Anesthesia Care Unit (PACU) will also be assessed.

Being tested
Dexmedetomidine, Placebo
Keywords
Environment, kgCO2eq

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex, Dexmedetomidine Hydrochloride, DIN : 02339366

    0.6 mcg/kg in infusion over 10 minutes

  • PlaceboDrug

    Also called Normal Saline, NaCl 0.9%

    Volume equivalent in infusion over 10 minutes

Study groups in NCT05615194
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNormal 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
Receives: Drug: Placebo
DexmedetomidineActive comparatorDexmedetomidine 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
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From intubation to end of surgery

Secondary outcomes (10)
  1. Total intra-operative remifentanil consumption (in mcg.kg-1)

    To compare the total intra-operative remifentanil consumption during anesthesia based on the NoL index (Medasense Ltd., Ramat Gan, Israel)

    Measured: From intubation to end of surgery

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

    To compare the percentage of time during the intraoperative period for which the NOL index will be above the pain threshold of 25

    Measured: From intubation to end of surgery

  3. Total amount of hydromorphone given IV in PACU (in mg)

    To quantify the total amount of hydromorphone needed in PACU

    Measured: From PACU admission to discharge

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

    To compare the intra- and post-operative requirements of phenylephrine, ephedrine, glycopyrrolate and atropine

    Measured: From intubation to PACU discharge

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

    To compare the mean end tidal sevoflurane (EtSevo) and MAC needed to maintain the BIS index between 40 and 60

    Measured: From intubation to end of surgery

  6. Total intraoperative time from intubation until end of surgery with BIS index between 40 and 60 (in minutes)

    To compare the % of total intraoperative time from intubation until end of surgery with BIS index between 40 and 60

    Measured: From intubation to end of surgery

  7. Time for extubation (in minutes)

    To compare the time for extubation

    Measured: From sevoflurane discontinuation to extubation

  8. Time for awakening (in minutes)

    To compare the time for awakening

    Measured: From sevoflurane discontinuation to when the patient is opening his eyes

  9. Postoperative outcomes such as postoperative nausea and vomiting (PONV), shivering and critical respiratory event (CRE)

    To assess postoperative outcomes such as postoperative nausea and vomiting (PONV), shivering and critical respiratory event (CRE)

    A CRE will be defined as the occurrence of one of the following criteria:

    • Upper airway obstruction requiring an intervention
    • Moderate hypoxemia: SpO2 of 90-93% on 2 L.min-1 nasal cannula O2
    • Severe hypoxemia: SpO2 < 90% on 2 L.min-1 nasal cannula O2
    • Signs of respiratory distress or impeding ventilatory failure
    • Patient requiring reintubation in the PACU
    • Clinical evidence or suspicion of pulmonary aspiration after tracheal extubation

    Measured: From PACU admission to discharge

  10. Total time spent in PACU (in minutes)

    To compare total time for readiness for discharge from PACU between groups assessed by recovery scores (Aldrete's modified score and Maisonneuve-Rosemont PACU score)

    Measured: From PACU admission to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start5 Dec 2022
  3. Primary completion1 Nov 2025
  4. Study completion1 Nov 2025

Why it stopped: Recruitment was too slow and difficult, we decided to prioritize other protocols that seem more clinically relevant

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615194
Sponsor's protocol ID
2023-3190
Status last verified
Oct 2026
First submitted
7 Nov 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine in people with Inhalation Anesthesia and Dexmedetomidine, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment was too slow and difficult, we decided to prioritize other protocols that seem more clinically relevant). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sevoflurane consumption expressed in mL.kg-1.h-1 (time frame: From intubation to end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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