Comparison between two intravenous sedatives in flexible bronchoscopy

Comparison of effects of intravenous Midazolam (0.035mg/kg)-Fentanyl(50mcg) combination and intravenous Dexmedetomidine (0.75mcg/kg)in flexible bronchoscopy - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060615

Enrollment

Registered

2023-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: J849- Interstitial pulmonary disease, unspecified

Interventions

Intervention1: Intravenous Midazolam(0.035mg/kg)-Fentanyl(50mcg): After inclusion criteria for the patients undergoing bronchoscopy are met ,patients are randomny allocated into group 1 or group 2 The

Eligibility

Inclusion criteria

Inclusion criteria: All patients in the age group 18 to 60 years undergoing flexible bronchoscopy in the department of respiratory medicine

Exclusion criteria

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) 6. Patients with psychiatric illness. 7. Hemodynamic instability including cardiac failure. 8. Second- or third-degree heart block/ Heart rate 9. Patients weighing less than 50kg or more than 70kg. 10. Pregnancy and lactation. 11. Hypovolemia. 12. Oxygen Saturation 13. Intervention failure cases will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1.Pain & distress measured by Numerical Rating Scale (NRS) 2. Visual Analogue Scale for cough 3. Ease of performing bronchoscopy 4. Modified Ramsay sedation score. 5. Number of intervention failure cases where 2nd dose of fentanyl was withheld 6. Post procedure patient response after 24 hoursTimepoint: 1.Pain & distress measured by Numerical Rating Scale (NRS) 2. Visual Analogue Scale for cough 3. Ease of performing bronchoscopy 4. Modified Ramsay sedation score. 5. Number of intervention failure cases where 2nd dose of fentanyl was withheld 6. Post procedure patient response after 24 hours	—

Measure

Time frame

1.Pain & distress measured by Numerical Rating Scale (NRS) 2. Visual Analogue Scale for cough 3. Ease of performing bronchoscopy 4. Modified Ramsay sedation score. 5. Number of intervention failure cases where 2nd dose of fentanyl was withheld 6. Post procedure patient response after 24 hoursTimepoint: 1.Pain & distress measured by Numerical Rating Scale (NRS) 2. Visual Analogue Scale for cough 3. Ease of performing bronchoscopy 4. Modified Ramsay sedation score. 5. Number of intervention failure cases where 2nd dose of fentanyl was withheld 6. Post procedure patient response after 24 hours

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Countries

India

Contacts

Public ContactDr.Rahul Magazine

kasturba Medical college and hospital

rahul.magazine@manipal.edu9901727204

Outcome results

None listed

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