Comparison between intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) in flexible bronchosopy- A prospective, randomized, double blinded study

Department of Respiratory Medicine, KMC Manipal1 site in 1 country72 target enrollmentStarted: November 24, 2023Last updated: July 11, 2023

Trial Snapshot

Phase: Phase 2/3
Status: Not yet recruiting
Sponsor
Enrollment: 72
Locations: 1
Primary Endpoint: Composite score during the bronchoscopy procedure

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 70.00 Year(s) (—)
Sex: All

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.

Outcomes

Primary Outcomes

Composite score during the bronchoscopy procedure

Time Frame: at the level of nasopharynx for 1 minute and at the time of passage through trachea for 1 minute

Secondary Outcomes

1. Ease of Performing bronchoscopy(2. pain and distress measured by Numerical Rating Scale)

Investigators

Sponsor

Department of Respiratory Medicine, KMC Manipal

Sponsor Class

Other [Deemed Medical College And Hospital]

Study Sites (1)

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