Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery
NCT Number: NCT06502002
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery-Complications|Respiratory Complication|Lung Injury, Acute
Interventions: DRUG: Dexmedetomidine Hydrochloride|DRUG: Placebo
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-31
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
This will be a randomized, placebo-controlled, double-blinded, pilot trial with two parallel groups (1:1 ratio) receiving either dexmedetomidine (initial bolus of 1 mcg/kg over 30 min after induction, followed by an infusion rate of 0.3 mcg/kg/hr that will be stopped 30-45 minutes before the end of the surgery or upon reaching maximum dose of 2mcg/kg, whichever comes first) or placebo (normal saline as a bolus followed by maintenance infusion at the same rate of the intervention group).

Dexmedetomidine is frequently administered in thoracic surgery. Using local data from the Brigham and Women's Hospital, dexmedetomidine was used in a third of the thoracic procedures performed over the past three years. However, there is no consensus as to the optimal protocol of administration, therefore clinical practice is highly heterogeneous (bolus versus continuous infusion) and mostly depends on the preferences of anesthesia providers. In our institution, the dose of dexmedetomidine is typically 0.5 mcg/kg but varies based on attending preferences and experience. Given the heterogenous practices in dexmedetomidine administration, one of the objectives is to assess the feasibility of adhering to a dexmedetomidine protocol using an initial loading dose of 1 mcg/kg over 30 minutes after induction followed by a continuous infusion of 0.3 mcg/kg/hr. The infusion will stop 30-45 minutes prior to the end of surgery or once a maximum dose of 2mcg/kg has been achieved, whichever comes first. The control group will receive normal saline (similar bolus followed by maintenance infusion at the same rate of the intervention group).

Primary Outcome Measures: Lung aeration, Lung aeration score measured by ultrasound at the post-anesthesia care unit (PACU) as described by Monastesse et al. Serial assessments will be performed at postoperative days 1 and 2., 2 days
Secondary Outcome Measures: Diaphragmatic dysfunction: defined as a diaphragmatic excursion < 1cm, diaphragmatic excursion measured by ultrasound, 2 days|Intraoperative hypoxemia (SpO2 < 90%), intraoperative hypoxemia measured by pulse oximetry, 1 day|Postoperative atelectasis, radiographic evidence of lung collapse, 30 days|Pneumonia, diagnosed by chest radiography (consolidations/opacifications), clinical or laboratory signs of infection, 30 days|Acute Respiratory Distress Syndrome (ARDS), Berlin Criteria (hypoxemia, sudden onset, absence of heart failure, bilateral infiltrates on chest radiograph), 30 days|Pulmonary edema, from chest radiograph (cephalization of vessel, diffuse opacification), 30 days|Reintubation, intubation of the trachea, application of mechanical ventilation, 30 days