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Comparison between intravenous Midazolam and intravenous Fentany in flexible bronchosopy.

Phase 2/3
Not yet recruiting
Conditions
Unspecified acute lower respiratory infection,
Registration Number
CTRI/2023/11/059704
Lead Sponsor
Department of Respiratory Medicine, KMC Manipal
Brief Summary

To study the effects of intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) on patient response to flexible bronchoscopy.

To assess and compare the patient response and comfort in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl.

To assess and compare the attenuation of pressor response in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
72
Inclusion Criteria

All patients in the age group 18 to 70 years, weighing 50-85kg and undergoing flexible bronchoscopy in the Department of Respiratory Medicine.

Exclusion Criteria

Patients with known or suspected allergy to Midazolam and Fentanyl, patients with Renal impairment, Hepatic impairment, seizure disorder, Psychiatric illness, hemodynamic instability including cardiac failure, second or third degree heart block, heart rate less than 50/ minute, COPD patients with Forced Expiratory Volume less than 50%, Pregnancy and Lactation, Oxygen saturation less than 90%, Platelet count less than 50, 000/ cubic milli meters.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite score during the bronchoscopy procedureat the level of nasopharynx for 1 minute and at the time of passage through trachea for 1 minute
Secondary Outcome Measures
NameTimeMethod
1. Ease of Performing bronchoscopy2. pain and distress measured by Numerical Rating Scale

Trial Locations

Locations (1)

KMC MANIPAL

🇮🇳

Udupi, KARNATAKA, India

KMC MANIPAL
🇮🇳Udupi, KARNATAKA, India
Dr Manish R Shetty
Principal investigator
9483870029
manishr213@gmail.com

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