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A study to compare two sedative medicines and find out which provides better comfort and recovery during flexible bronchoscopy in adults

Comparison of Midazolam fentanyl vs propofol on procedural comfort and recovery in flexible bronchoscopy A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113784
Enrollment
150
Registered
2026-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Propofol group: Propofol will be administered as an initial intravenous dose of 20 mg followed by additional doses based on the patients American Society of Anaesthesiologists classific

Sponsors

AIIMS, Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged more or equal to 18 years scheduled for flexible bronchoscopy Indicated for diagnostic procedures such as brushing washings bronchoalveolar lavage or endobronchial or transbronchial biopsy Ability & willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: Age less than 18 years Renal or hepatic insufficiency Seizure disorder or psychiatric illness Hemodynamic instability including ding cardiac failure hypovolemia heart rate less than 50 beats per min or second or third degree heart block Known or suspected allergy to midazolam fentanyl or propofol Pregnancy or Lactation Patient unwilling or unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
To compare the composite procedural comfort scores among the two sedation regimens. Timepoint: Assessed during flexible bronchoscopy and recorded at the end of the procedure

Secondary

MeasureTime frame
Recovery time measured using the Modified Observer Assessment of Alertness Sedation score. Timepoint: Immediately after completion of bronchoscopy until achievement of a Modified Observer Assessment of Alertness Sedation score of 5.;Patient reported discomfort and procedure related cough severity measured using a 10 cm visual analogue scale. Timepoint: After recovery immediately after achievement of a Modified Observer Assessment of Alertness Sedation score of 5 and before discharge.

Countries

India

Contacts

Public ContactDr Alkesh Kumar Khurana

AIIMS, Bhopal

alkesh.pulmed@aiimsbhopal.edu.in7773010091

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026