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

100 Participants Needed

Trial Summary

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.

What data supports the idea that Dexmedetomidine for Postoperative Lung Complications is an effective drug?

The available research shows that Dexmedetomidine may help reduce lung problems after surgery. In a study involving patients who had oral and maxillofacial surgery, it was suggested that Dexmedetomidine could lower the chances of lung complications. Another analysis found that Dexmedetomidine improved lung function during certain types of lung surgery. These findings suggest that Dexmedetomidine might be effective in preventing lung issues after surgery. ^{1 2 3 4 5}

What safety data exists for dexmedetomidine?

Dexmedetomidine, also known as Precedex, has been evaluated for safety in various contexts. It is frequently used as a sedative during surgical procedures and is generally considered safe, though there are reports of serious adverse events such as cardiac arrest in specific cases, like in a patient with a pacemaker. It has been used in pediatric airway reconstruction and shown to reduce perioperative respiratory adverse events in children. Additionally, it is used as an adjuvant analgesic for cancer pain without causing respiratory depression. However, it can decrease heart rate and increase post-anesthesia care unit stay duration. Overall, dexmedetomidine is effective in improving airway function and reducing risks associated with general anesthesia, but caution is advised in certain populations. ^{1 2 6 7 8}

Is the drug Dexmedetomidine a promising treatment for postoperative lung complications?

Yes, Dexmedetomidine is promising for postoperative lung complications because it reduces the need for opioids, which can cause breathing problems, and provides effective pain relief and sedation without significant respiratory depression. ^{1 2 5 9 10}

What is the purpose of this trial?

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).

Research Team

Matthew B Allen, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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)

I have had other surgeries not related to my lungs.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. [2013]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine improves pulmonary outcomes in thoracic surgery under one-lung ventilation: A meta-analysis. [2023]

5. France pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

7. Iran 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. [2022]

8. Greece 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. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: a guide to its use for sedation in the US. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine infusion for analgesia up to 48 hours after lung surgery performed by lateral thoracotomy. [2022]