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Comparison between intravenous Midazolam and intravenous Fentany in flexible bronchosopy.

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059704
Enrollment
72
Registered
2023-11-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Either Intravenous Midazolam (0.035mg/kg) or Intravenous fentanyl (50mcg) on Patient response to flexible bronchoscopy: After the inclusion criteria for the patients undergoing bronchos

Sponsors

Department of Respiratory Medicine, KMC Manipal
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
1. Ease of Performing bronchoscopy 2. pain and distress measured by Numerical Rating Scale 3. Visual Analogue Scale for Cough 4. Modified ramsay Sedation Score 5. Post procedure patient response after 24 hoursTimepoint: 1. Ease of Performing bronchoscopy 2. pain and distress measured by Numerical Rating Scale 3. Visual Analogue Scale for Cough 4. Modified ramsay Sedation Score 5. Post procedure patient response after 24 hours

Countries

India

Contacts

Public ContactDr Manish R Shetty

Kasturba Medical College and Hospital, MAHE, Manipal

rahul.magazine@manipal.edu9901727204

Outcome results

None listed

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