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Clinical Trials/NCT05615194
NCT05615194
Recruiting
Not Applicable

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

Ciusss de L'Est de l'Île de Montréal1 site in 1 country84 target enrollmentDecember 5, 2022

Overview

Phase
Not Applicable
Intervention
Placebo
Conditions
Inhalation Anesthesia
Sponsor
Ciusss de L'Est de l'Île de Montréal
Enrollment
84
Locations
1
Primary Endpoint
Sevoflurane consumption expressed in mL.kg-1.h-1
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 5, 2022
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ciusss de L'Est de l'Île de Montréal
Responsible Party
Principal Investigator
Principal Investigator

Olivier Verdonck

Assistant Professor, Deputy chief of the Department of Anesthesiology of Maisonneuve-Rosemont Hospital, University of Montreal(UDeM)

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Placebo

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

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

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

Time Frame: From intubation to end of surgery

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.

Secondary Outcomes

  • Total amount of hydromorphone given IV in PACU (in mg)(From PACU admission to discharge)
  • 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)
  • 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)
  • Total intraoperative time from intubation until end of surgery with BIS index between 40 and 60 (in minutes)(From intubation to end of surgery)
  • Time for extubation (in minutes)(From sevoflurane discontinuation to extubation)
  • Time for awakening (in minutes)(From sevoflurane discontinuation to when the patient is opening his eyes)
  • Postoperative outcomes such as postoperative nausea and vomiting (PONV), shivering and critical respiratory event (CRE)(From PACU admission to discharge)
  • Total time spent in PACU (in minutes)(From PACU admission to discharge)

Study Sites (1)

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