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Tests treatment safety and results for Medical Thoracoscopy
Official title Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
ClinicalTrials.gov ID: NCT07184801
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for medical thoracoscopy.
Also referred to as Dexmed.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Medical thoracoscopy can be performed under procedural sedation (conscious sedation) in most of the cases. Procedural sedation is a state where the patient lies comfortably without much movement, does not feel pain and has a dissociative state (separation of mind and body.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 90
You may be able to join if
- Age≥18 and ≤80 years
- Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
You likely can't join if
- Patients with ICD in situ for more than 5 days
- SP02\<92%
- Haemodynamic instability (systolic blood pressure ≤90 mmHg or \>180mmHg, or diastolic BP \>110mmHg) before the procedure
- MI/unstable angina in the last 3 months
- Hb\<8g/dL, platelet\<50000 cells/dL
- Lack of pleural space due to adhesion
See the full eligibility criteria
- Age≥18 and ≤80 years
- Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
- Patients with ICD in situ for more than 5 days
- SP02\<92%
- Haemodynamic instability (systolic blood pressure ≤90 mmHg or \>180mmHg, or diastolic BP \>110mmHg) before the procedure
- MI/unstable angina in the last 3 months
- Hb\<8g/dL, platelet\<50000 cells/dL
- Lack of pleural space due to adhesion
- Uncorrected coagulopathy (PT\>3 secs above control; APTT\>10 secs above control
- Failure to provide informed consent
- Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study
- Patients who required any anaesthetic/analgesic agent in past 7 days
- Patients on psychotropic drugs that may alter sensorium
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, Chandigarh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.