Dexmedetomidine for Postoperative Lung Complications

Overseen By Matthew B Allen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Emergency surgery, Prior lung surgery, Arrhythmia, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to evaluate a new protocol for using dexmedetomidine, a medication often used during thoracic surgery, to determine if it can reduce lung complications post-surgery. Participants will receive either dexmedetomidine or a placebo (a harmless substance resembling the real medication) to compare results. The goal is to identify the best method for administering this medication during surgery. The trial seeks adults planning to undergo specific lung surgeries, such as lobectomy or segmentectomy. As an unphased trial, it offers participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dexmedetomidine is often used in chest surgeries and has undergone extensive safety studies. Studies have found that dexmedetomidine is usually well-tolerated and can help improve lung function after surgery. For instance, patients using dexmedetomidine are less likely to experience issues like atelectasis, where the lungs don't fully expand.

Regarding safety, dexmedetomidine is already used in many surgeries without major problems, providing substantial evidence of its safety in people. While some side effects, such as low blood pressure or a slow heart rate, can occur, these are usually manageable. Overall, dexmedetomidine has been safely used in many surgical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for preventing postoperative lung complications, which often involves mechanical ventilation and other supportive therapies, dexmedetomidine offers a unique approach. It works as a sedative with the ability to reduce the body's stress response and inflammation during surgery. Researchers are excited about dexmedetomidine because it targets specific receptors in the brain, potentially reducing the risk of lung complications without the extensive side effects associated with other sedatives. This could lead to quicker recovery times and improved outcomes for patients undergoing surgery.

What evidence suggests that dexmedetomidine might be an effective treatment for postoperative lung complications?

Research has shown that dexmedetomidine, which participants in this trial may receive, can significantly reduce the risk of lung problems after surgery. A combined analysis of studies found it decreases the likelihood of lung issues by 56% (odds ratio of 0.44). Another study discovered that dexmedetomidine lowers the risk of lung collapse (atelectasis) by 46% and low blood oxygen (hypoxemia) by 57%. These findings suggest that dexmedetomidine can improve lung function during and after surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Matthew B Allen, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for patients undergoing thoracic surgery who may benefit from a drug called Dexmedetomidine to improve lung function post-surgery. The study excludes those with specific health conditions or factors that could interfere with the trial's outcomes, but details on these are not provided.

Exclusion Criteria

I need urgent or emergency surgery in my chest area.

Preoperative hypotension (mean arterial blood pressure < 65 mmHg)

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either dexmedetomidine or placebo during thoracic surgery, with dexmedetomidine administered as an initial bolus followed by continuous infusion.

During surgery

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored in the post-anesthesia care unit (PACU) with lung aeration scores measured by ultrasound.

2 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness, including assessment of pulmonary complications.

30 days

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Dexmedetomidine Infusion

Trial Overview The study tests if Dexmedetomidine, given as an initial bolus and then infused during surgery, can help maintain better lung aeration after thoracic surgery compared to a placebo (saline solution). Participants will be randomly assigned to either the drug or placebo group in equal numbers.

How Is the Trial Designed?

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

Dexmedetomidine infusion arm

Group II: Placebo Placebo Group 1 Intervention

Normal saline infusion arm

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

In a meta-analysis of 12 randomized trials involving 724 patients, dexmedetomidine significantly reduced the incidence of postoperative atelectasis (2.3% vs 6.8%) and hypoxemia (3.4% vs 11.7%) compared to placebo, suggesting it may improve respiratory outcomes after thoracic surgery.

Patients receiving dexmedetomidine also showed better intraoperative respiratory mechanics and postoperative lung function, with higher respiratory compliance and forced expiratory volume, indicating potential benefits in lung function during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine improves pulmonary outcomes in thoracic surgery under one-lung ventilation: A meta-analysis. Zorrilla-Vaca, A., Grant, MC., Law, M., et al.[2023]

Intravenous dexmedetomidine is effective for sedation in mechanically ventilated patients and during procedures, reducing the need for additional sedatives like propofol or midazolam.

It is generally well tolerated, does not cause respiratory depression, and while it may lead to hypotension and bradycardia, these side effects typically resolve on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: a guide to its use for sedation in the US. Keating, GM., Hoy, SM., Lyseng-Williamson, KA.[2022]

Dexmedetomidine was safely used to sedate a pediatric patient during 12 radiation therapy sessions, demonstrating its effectiveness as a sedative and anesthetic adjuvant.

The use of dexmedetomidine resulted in smooth induction and quick recovery while causing minimal respiratory depression, highlighting its favorable safety profile in pediatric sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. Shukry, M., Ramadhyani, U.[2013]

In a study of 38 patients undergoing thoracotomy, dexmedetomidine infusion reduced opioid consumption by 41% while maintaining similar pain control compared to a placebo, highlighting its effectiveness as an opioid-sparing agent.

Patients receiving dexmedetomidine experienced fewer opioid-related adverse events and significant respiratory depression was only observed in the placebo group, suggesting that dexmedetomidine may enhance safety in postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine infusion for analgesia up to 48 hours after lung surgery performed by lateral thoracotomy. Ramsay, MA., Newman, KB., Leeper, B., et al.[2022]

Dexmedetomidine is an alpha-2 adrenergic agonist that provides sedation and pain relief without causing respiratory depression, making it a safe option for patients requiring sedation.

In a case study, dexmedetomidine was effectively used as an adjuvant analgesic for a patient with cancer pain that did not respond to other treatments, highlighting its potential role in managing complex pain scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. Roberts, SB., Wozencraft, CP., Coyne, PJ., et al.[2013]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

In a study of 160 patients undergoing oral and maxillofacial surgery, continuous infusion of dexmedetomidine (DEX) significantly reduced the incidence of postoperative pulmonary complications (PPCs) from 40% in the placebo group to 22.5% in the DEX group within the first 7 days after surgery.

DEX treatment not only lowered the occurrence of PPCs but also improved postoperative survival probability without increasing the risk of bradycardia or hypotension, indicating its safety and efficacy in high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial. Liu, Y., Zhu, X., Zhou, D., et al.[2022]

Dexmedetomidine significantly reduces the incidence of perioperative respiratory adverse events (PRAEs) such as cough, breath holding, and laryngospasm in children, based on a meta-analysis of 10 randomized controlled trials involving 1,056 patients.

In addition to lowering the risk of PRAEs, dexmedetomidine also decreases heart rate and extends post-anesthesia care unit stay by about 11 minutes, indicating its potential to improve airway function and safety during pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. Zhang, J., Yin, J., Li, Y., et al.[2023]

In a study of 100 opium users undergoing elective brain tumor surgery, premedication with dexmedetomidine significantly reduced the rates of postoperative nausea and vomiting (PONV) and shivering compared to a placebo group.

The results indicate that dexmedetomidine can be an effective premedication to improve recovery outcomes in patients at risk for these complications, with significant differences observed in both PONV (P=0.001) and shivering (P=0.027).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dexmedetomidine On the Postoperative Shivering, Nausea, and Vomiting Among Opium User Patients Undergoing Elective Supratentorial Brain Tumor Surgery: A Randomized, Placebo, Controlled Clinical trials. Mona, R., Davood, O., Alireza, Z., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10718632/

a meta-analysis of randomized controlled trial - PMC This meta-analysis showed that dexmedetomidine significantly decreased the incidence of postoperative pulmonary complications (OR: 0.44, 95% CI [0.24, 0.82], P ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818023002957

Dexmedetomidine improves pulmonary outcomes in ... Findings: Dexmedetomidine reduces the odds of postoperative atelectasis and hypoxemia by 46% and 57%, respectively, but there is insufficient evidence to ...

3. withpower.com withpower.com/trial/phase-respiratory-complications-7-2024-4472d

Dexmedetomidine for Postoperative Lung Complications Another analysis found that Dexmedetomidine improved lung function during certain types of lung surgery. These findings suggest that Dexmedetomidine might be ...

4. ekja.org ekja.org/upload/pdf/kja-22787.pdf

Effects of dexmedetomidine on pulmonary function in ... This meta-analysis found that dexmedetomidine decreased the incidence of postoperative pulmonary complications significantly. (OR = 0.44, 95% CI:0.24, 0.82 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06502002?cond=%22Acute%20Lung%20Injury%22&intr=%22narcotics%22&viewType=Table&rank=6

Dexmedetomidine Infusion and Postoperative Lung Aeration ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7251859/

Dexmedetomidine for prevention of postoperative ... We analysed outcome data and safety in the intention-to-treat population. Statistical analyses were performed on SPSS version 24.0 software (SPSS, Chicago ...

7. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/dexmedetomidine-improves-pulmonary-outcomes-in-thoracic-surgery-u/

Dexmedetomidine improves pulmonary outcomes in ... Conclusion: Dexmedetomidine administration during thoracic surgery may potentially reduce the risk of postoperative atelectasis and hypoxemia. However, current ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034816/

Dexmedetomidine improves pulmonary outcomes in thoracic ... Nine trials reported data of one or more postoperative pulmonary complications. Patients in the dexmedetomidine group were less likely to develop atelectasis ( ...