COMPLETED

Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery: A Randomized, Placebo-Controlled Pilot Trial

Quick Facts

Study Start:2024-08-01
Study Completion:2025-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06502002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Urgent or emergency thoracic surgery.
  2. * Other concomitant non-pulmonary procedures (pleurectomy, diaphragmatic procedures, pericardiocentesis, esophageal procedures, thymectomy).
  3. * Prior lung resection surgery.
  4. * Epidural block for intraoperative or postoperative analgesia.
  5. * Preoperative arrhythmia (second degree AV block or pacemaker) or significant bradycardia (heart rate \< 50).
  6. * Preoperative hypotension (mean arterial blood pressure \< 65 mmHg).
  7. * Severe functional liver or kidney disease.
  8. * Non-English speakers
  9. * Consent withdrawal.

Contacts and Locations

Principal Investigator

Matthew B Allen, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Matthew B Allen, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2025-11-15

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2025-11-15

Terms related to this study

Keywords Provided by Researchers

  • dexmedetomidine
  • lung ultrasound
  • lung resection
  • thoracic surgery
  • aeration

Additional Relevant MeSH Terms

  • Surgery-Complications
  • Respiratory Complication
  • Lung Injury, Acute