Anesthesia vs Sedation for Lung Lesions

(RESSOURCE Trial)

Overseen By Marc Fortin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Disqualifiers: Pregnancy, Unstable condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

306 Participants Needed

Trial Summary

What is the purpose of this trial?

The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for lung lesions?

Research suggests that peripheral nerve blocks, which are similar to the anesthesia methods used in this trial, can reduce pain and nausea after surgery, potentially leading to a shorter recovery time in the postanesthesia care unit. ^{1 2 3 4 5}

Is anesthesia or sedation for lung procedures generally safe?

Both anesthesia and sedation for lung procedures are generally safe, with rare risks of nerve injury or local anesthetic toxicity. These risks are not higher when performed under general anesthesia or deep sedation compared to when patients are awake or lightly sedated. ^{4 6 7 8 9}

How does the treatment of Peripheral EBUS under Conscious Sedation or General Anesthesia for lung lesions differ from other treatments?

Peripheral EBUS (endobronchial ultrasound) under conscious sedation or general anesthesia is unique because it allows for a detailed examination and sampling of lung lesions with different sedation levels, which can impact the procedure's safety, cost, and diagnostic yield. This approach is particularly useful for accessing and analyzing peripheral lung lesions, offering repeatable access and protection against bleeding, which is not typically available with other standard lung examination methods. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for individuals with lung lesions, potentially due to cancer. Participants should be suitable for a procedure called peripheral endobronchial ultrasound (pEBUS), which can be done under either conscious sedation or general anesthesia.

Inclusion Criteria

My lung lesion is smaller than 5cm on a CT scan.

Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist

My doctor and I have agreed to use pEBUS for diagnosing my lung issue.

Exclusion Criteria

Current pregnancy

Lack of free and informed consent

I have large or highly active lymph nodes that can be checked with a special scope.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person, phone, or telemedicine)

Randomization and Procedure

Participants are randomized to either general anesthesia or conscious sedation and undergo the pEBUS procedure

1 day

1 visit (in-person)

Immediate Post-Procedure Recovery

Participants recover from the procedure and complete comfort questionnaires before discharge

Same day as procedure

1 visit (in-person)

Follow-up

Participants' medical records are reviewed for results and late complications; follow-up continues at 1 and 2 years if the procedure is not diagnostic

2 years

Treatment Details

Interventions

• Peripheral EBUS under Conscious Sedation
• Peripheral EBUS under General Anesthesia

Trial Overview The study aims to compare the effectiveness of pEBUS when performed under two different conditions: conscious sedation and general anesthesia. The goal is to determine which method provides better diagnostic results and patient comfort.

Participant Groups

Group I: General anesthesia arm Experimental Treatment 1 Intervention

In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RAS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RAS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol

Group II: Conscious sedation arm Experimental Treatment 1 Intervention

In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RAS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study.

Who Is Running the Clinical Trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials

26

Recruited

6,300+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Nerve localization for peripheral regional anesthesia. Recommendations of the German Society of Anaesthesiology and Intensive Care Medicine. [2021]

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

'SCALD-ED' Block: Superficial Cutaneous Anesthesia in a Lateral Leg Distribution within the Emergency Department - A Case Series. [2019]

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

A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Incidence of local anesthetic systemic toxicity and postoperative neurologic symptoms associated with 12,668 ultrasound-guided nerve blocks: an analysis from a prospective clinical registry. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of peripheral nerve blocks on postanesthesia care unit length of stay in patients undergoing ambulatory surgery: a retrospective cohort study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Peripheral regional anesthesia in patients under general anesthesia: risk assessment with respect to parasthesia, injection pain and nerve damage]. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Epidural anesthesia in awake thoracic surgery. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of epidural anesthesia on intrathoracic blood volume and extravascular lung water during on-pump cardiac surgery. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

[Risks and dangers in pediatric regional anesthesia]. [2021]

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

Diagnostic Yield and Complications of EBUS-TBNA Performed Under Bronchoscopist-directed Conscious Sedation: Single Center Experience of 1004 Subjects. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Impact of Moderate Sedation versus Monitored Anesthesia Care on Outcomes and Cost of Endobronchial Ultrasound Transbronchial Needle Aspiration. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus bronchoscopist-directed deep sedation: A retrospective analysis. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Safety of geriatric patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration with deep sedation: a retrospective study. [2023]

14. Japan pubmed.ncbi.nlm.nih.gov

[Ultrasound, bronchoscopy]. [2010]