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

2023-3190

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.

2022-12-05

2023-09-01

2023-09-01

Recruiting

84

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nThe 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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "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.\n\nThe 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.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

2023-02-15