Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery

NCT06502002 | Completed

• 1 other identifier: 2023P001017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Surgery-Complications; Respiratory Complication; Lung Injury, Acute

Keywords

dexmedetomidine; lung ultrasound; lung resection; thoracic surgery; aeration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Diaphragmatic dysfunction: defined as a diaphragmatic excursion < 1cm

  2 days

• Intraoperative hypoxemia (SpO2 < 90%)

  1 day

• Postoperative atelectasis

  30 days

• Pneumonia

  30 days

• Acute Respiratory Distress Syndrome (ARDS)

  30 days

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine infusion arm

Drug: Dexmedetomidine Hydrochloride

Placebo

PLACEBO COMPARATOR

Normal saline infusion arm

Drug: Placebo

Interventions

Dexmedetomidine Hydrochloride DRUG

Initial dexmedetomidine 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 once a maximum dose of 2mcg/kg has been achieved, whichever comes first.

Also known as: Precedex

Dexmedetomidine

Placebo DRUG

normal saline infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (Age \>18 years until 80 years) undergoing lobectomy and/or segmentectomy.

You may not qualify if:

• Urgent or emergency thoracic surgery.
• Other concomitant non-pulmonary procedures (pleurectomy, diaphragmatic procedures, pericardiocentesis, esophageal procedures, thymectomy).
• Prior lung resection surgery.
• Epidural block for intraoperative or postoperative analgesia.
• Preoperative arrhythmia (second degree AV block or pacemaker) or significant bradycardia (heart rate \< 50).
• Preoperative hypotension (mean arterial blood pressure \< 65 mmHg).
• Severe functional liver or kidney disease.
• Non-English speakers
• Consent withdrawal.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Dell'Aquila P, Raimondo P, Racanelli V, De Luca P, De Matteis S, Pistone A, Melodia R, Crudele L, Lomazzo D, Solimando AG, Moschetta A, Vacca A, Grasso S, Procacci V, Orso D, Vetrugno L. Integrated lung ultrasound score for early clinical decision-making in patients with COVID-19: results and implications. Ultrasound J. 2022 Jun 1;14(1):21. doi: 10.1186/s13089-022-00264-8.

  PMID: 35648278 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthew B Allen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Dexmedetomidine or placebo infusion will be blinded (by pharmacist preparing the study drug) to the patient, treating physicians, and investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Model Details: This will be a randomized, placebo-controlled, double-blinded, pilot trial with two parallel groups (1:1 ratio) receiving either dexmedetomidine) or placebo

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: November 13, 2025
• Study Completion: November 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)