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A Study to compare Midazolam vs. Fentanyl for sedation during Diagnostic bronchoscopy.

A Prospective, Randomized, Double Blind Study to compare safety and comfort of Midazolam vs. Fentanyl administration during Diagnostic flexibile bronchoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050603
Enrollment
50
Registered
2023-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: Intravenous Fentanyl: Intravenous Fentanyl - 0.5 mcg/Kg/dose given at start of bronchoscopy. Control Intervention1: Intravenous Midazolam: Intravenous Midazolam - 0.035 mg/kg/dose given

Sponsors

ACS Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in the age group of 18–70 years who were advised flexible bronchoscopy for diagnostic workup

Exclusion criteria

Exclusion criteria: 1.Severe cardiac & Respiratory impairment 2.Bleeding diathesis 3.Not willing for procedure 4.Depression of consciousness or cognitive impairment rendering them unable to answer the questionnaires 5.History of hypersensitivity or contraindications to the drugs used in the study.

Design outcomes

Primary

MeasureTime frame
1.Haemodynamic and respiratory parameters. 2.Ramsay sedation score(RSS) during the procedure. 3.Composite score of bronchoscopist reported comfort level during the procedure. 4.Composite score of patient-reported tolerance and satisfaction with the procedure.Timepoint: 1.Baseline , every 10 minutes till the end of procedure,10 minutes post procedure 2.10 minutes after intravenous sedation. 3.Questionarie for the bronchoscopist will be administered after procedure 4.Questionarie for the patient will be administered after 6 hours of procedure.

Secondary

MeasureTime frame
1.Comparision of Rescue doses across two groups. 2.Lignocaine dose used.Timepoint: During the procedure

Countries

India

Contacts

Public ContactMohanakrishnan Deivasigamani

ACS Medical College and Hospital

drcc.ghtm@gmail.com9941198101

Outcome results

None listed

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