Comparison between two intravenous sedatives in flexible bronchoscopy
Phase 2
- Conditions
- Health Condition 1: J849- Interstitial pulmonary disease, unspecified
- Registration Number
- CTRI/2023/12/060615
- Lead Sponsor
- DrSravya putta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients in the age group 18 to 60 years undergoing flexible bronchoscopy in the department of respiratory medicine
Exclusion Criteria
1. Patients with known or suspected allergy to Midazolam or Dexmedetomidine.
2. Patients with renal impairment
3. Patients with hepatic impairment
4. Patients with seizure disorder.
5. COPD patients with Forced Expiratory Volume (FEV1) < 50%.
6. Patients with psychiatric illness.
7. Hemodynamic instability including cardiac failure.
8. Second- or third-degree heart block/ Heart rate <50/min
9. Patients weighing less than 50kg or more than 70kg.
10. Pregnancy and lactation.
11. Hypovolemia.
12. Oxygen Saturation < 90%
13. Intervention failure cases will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite score during the bronchoscopy procedureTimepoint: At the level of nasopharynx for 1 minute and at the time of passage through trachea for 1 minute
- Secondary Outcome Measures
Name Time Method 1.Pain & distress measured by Numerical Rating Scale (NRS) <br/ ><br>2. Visual Analogue Scale for cough <br/ ><br>3. Ease of performing bronchoscopy <br/ ><br>4. Modified Ramsay sedation score. <br/ ><br>5. Number of intervention failure cases where 2nd dose of fentanyl was withheld <br/ ><br>6. Post procedure patient response after 24 hoursTimepoint: 1.Pain & distress measured by Numerical Rating Scale (NRS) <br/ ><br>2. Visual Analogue Scale for cough <br/ ><br>3. Ease of performing bronchoscopy <br/ ><br>4. Modified Ramsay sedation score. <br/ ><br>5. Number of intervention failure cases where 2nd dose of fentanyl was withheld <br/ ><br>6. Post procedure patient response after 24 hours