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Comparison between two sedatives used for anaesthesia during bronchoscopy procedure

Comparison between intravenous Midazolam(0.035mg/Kg)-Fentanyl (25mcg)combination and intravenous Dexmedetomidine(0.75mcg/kg) in flexible bronchoscopy- A prospective, randomized, double blinded study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023254
Enrollment
62
Registered
2020-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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: Intravenous Dexmedetomidine(0.75mcg/kg). : Intravenous Dexmedetomidine (0.75mcg/kg)in flexible bronchoscopy. duration of therapy will be only so long as to give the adequate sedation d

Sponsors

Kasturba Medical College Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients in the age group 18 to 65 years undergoing flexible bronchoscopy in the Department of Respiratory Medicine.

Exclusion criteria

Exclusion criteria: 1. Patients with known or suspected allergy to Midazolam or Dexmedetomidine. 2. Patients with renal impairment 3. Patients with hepatic impairment 4. Patients with seizure disorder. 5. COPD patients with Forced Expiratory Volume (FEV1 ) 6. Patients with psychiatric illness. 7. Haemodynamic instability including cardiac failure. 8. Second or third degree heart block/ Heart rate 9. Patients weighing more than 70kg. 10. Pregnancy and lactation. 11. Hypovolemia. 12. Oxygen Saturation

Design outcomes

Primary

MeasureTime frame
To study the effects of intravenous Midazolam(0.035mg/kg)-Fentanyl(25mcg) combination and intravenous Dexmedetomidine (0.75mcg/kg) on patient response to flexible bronchoscopy.Timepoint: before the administration of study drugs, at the start of flexible bronchoscopy, 5 minutes after the start of bronchoscopy, 10 minutes after the start of bronchoscopy and 10 minutes after the completion of bronchoscopy—

Secondary

MeasureTime frame
1. Duration of bronchoscopy procedure. 2. Number of doses of rescue medication given. 3. Haemodynamic parameters 4. Total dose of Lignocaine used 5. Oxygen saturation 6. Diagnostic procedures done during bronchoscopyTimepoint: At 0 minutes, 2 minutes into the procedure, at the end of precedure, 5 minutes after the procedure—

Countries

India

Contacts

Public ContactVrinda Mariya Elenjickal

Kasturba Medical College, Manipal

vrinda46@gmail.com9986822148

Outcome results

None listed

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