midazolam / fentanyl combined in EBUS-TBNA

JRCT ID: jRCTs051210131

Registered date:10/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lung cancer, Mediastinal tumor, Mediastinal lymphadenopathy
• Date of first enrollment: 16/12/2021
• Target sample size: 98
• Study type: Interventional

Intervention(s)

Midazolam group Placebo 3 mL+ midazolam 2 mg
Midazolam + fentanyl group fentanyl 30 microg /3 ml + midazolam 2 mg
Is intravenously administered immediately before the start of respiratory endoscopy

Outcome(s)

Primary Outcome

The rate of patients who meet all of the following during bronchoscopy
1) The MOAA/S scale 3-4 or BIS level 70-80 is reached as a sufficient sedation depth
2) As an evaluation of good sedative effect, the number of additions of midazolam + fentanyl/placebo within 30 minutes after the start of the test 2 times or less
3) Number of punctures 3 times or more as an index to complete the examination

Secondary Outcome

1) The rate of patients who meet all of the following during bronchoscopy
1.The MOAA/S scale 3-4 or BIS level 70-80 is reached as a sufficient sedation depth
2. As an evaluation of good sedative effect, the number of additions of midazolam + fentanyl/placebo within 30 minutes after the start of the test 3 times or less
3. Number of punctures 3 times or more as an index to complete the examination
2)VAS value indicating the degree of pain including physical pain and mental pain during bronchoscopy
3) Dosage of lidocaine, midazolam, and fentanyl
4) MOAA / S scale, SpO2, oxygen requirement, respiratory rate, blood pressure, pulse rate, complications
5) Whether or not flumazenil is used
6) adverse events
7) Examiner satisfaction
8) Diagnosis rate, test time, test interruption rate and interruption time, BIS value

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) over20 years old
(2) EBUS-TBNA is scheduled to be performed for the purpose of biopsy of mediastinal lesions.
(3) Document consent can be obtained by the patient regarding participation in this study

Exclude criteria

(1) drug hypersensitivity constitution such as allergies to the drugs used in this study.
(2) Have acute narrow-angle glaucoma
(3) Have myasthenia gravis
(4) Have uncontrollable bronchial asthma
(5) Being in a spastic state
(6) Taking HIV protease inhibitor or nalmefene
(7) The use of muscle relaxants is contraindicated
(8) Prone to respiratory depression such as coma due to head injury, brain tumor, etc.
(9) Taking opioids
(10) Others who are judged to be inappropriate by the person in charge of this test

Related Information

• Primary Sponsor: Tachihara Motoko