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An exploratory study on the clinical application of mild-to-moderate sedation techniques for enhancing the precision of surgical navigation robot-assisted percutaneous lung biopsy

An exploratory study on the clinical application of mild-to-moderate sedation techniques for enhancing the precision of surgical navigation robot-assisted percutaneous lung biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113528
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-30
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental group:Subjects in this group received an initial intravenous injection of a combination of "midazolam and sufentanil," with midazolam administered at a dose of 0.03-0.05 mg/kg and sufenta
Control group:Participants in this group underwent standard surgical procedures for respiratory training. Once they were able to control their breathing as instructed, percutaneous lung puncture was c

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 and < 80 years, with no gender restrictions; 2. Patients scheduled for percutaneous puncture intervention in the lungs, encompassing procedures such as percutaneous biopsy and tumor ablation; 3. Patients willing to undergo mild to moderate sedation; 4. Patients in good general condition, classified as American Society of Anesthesiologists (ASA) Health Status Grades I or II; Patients with ASA Grades III or IV in a stable condition should be closely monitored during the procedure; 5.The patient fully comprehends the benefits and risks associated with this trial, is willing to participate, and has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients presenting with skin redness, swelling, damage, symptoms of skin diseases, or an inability to affix markers due to skin conditions at the puncture site, as well as those with acute suppurative infections in the pleural cavity; 2.Patients with a platelet count below 50 × 10^9/L, severe bleeding tendencies, or coagulation disorders that cannot be promptly corrected (prothrombin time exceeding 18s, prothrombin activity below 40%), or those who have discontinued anticoagulant and/or antiplatelet therapy no more than 5-7 days prior to ablation, and whose last use of bevacizumab was within the past month; 3.Patients with severe systemic infections and high fever (>38.5?); 4. Patients with pneumothorax risk due to other conditions such as pulmonary bullae or pulmonary cysts along the intended puncture path; 5. Patients with poorly controlled pleural effusion; 6. Critically ill patients with severe dysfunction of the heart, liver, lungs, or kidneys; 7. Patients unable to cooperate or tolerate the puncture procedure; 8. Women who are pregnant or breastfeeding, as well as individuals who cannot be exposed to intraoperative radiation; 9. Patients classified as ASA grade V; 10. Applicable only to the mild to moderate sedation group: patients without an accompanying person or guardian; 11. Patients with allergies to sedatives/anesthetics or those at extremely high anesthesia risk; 12.Patients who have participated or are currently participating in another clinical trial within the 28 days prior to screening; 13. Patients deemed by researchers to have poor compliance or other reasons unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Puncture accuracy;

Secondary

MeasureTime frame
Puncture accuracy rate;Puncture time;Number of punctures;Displacement of pulmonary nodules;Puncture difficulty VAS score;

Countries

China

Contacts

Public ContactLin Xinqing

The First Affiliated Hospital of Guangzhou Medical University

linxinqing81@163.com+86 130 6886 3939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026