FindTrial
Sign In

Comparison between dexmedetomidine vs midazolam for sedation in bronchoscopy

Comparison between intravenous 0.75 mcg/kg dexmedetomidine vs 0.035mg/kg midazolam in flexible bronchoscopy â?? A prospective, randomized, double blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014563
Enrollment
48
Registered
2018-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- All patients in the age group 18 to 65 years requiring flexible bronchoscopy in the Department of Respiratory Medicine. Health Condition 2: C340- Malignant neoplasm of main bronchus Health Condition 3: J848- Other specified interstitial pulmonary diseases Health Condition 4: J168- Pneumonia due to other specified infectious organisms

Interventions

Intervention1: Dexmedetomidine: Intravenous dexmedetomidine 0.75 mcg/kg, single dose, given at onset of bronchoscopy over 10 minutes Control Intervention1: Midazolam: Intravenous Midazolam 0.035mg/kg

Sponsors

Kasturba Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients in the age group 18 to 65 years requiring 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 or hepatic insufficiency. 3.Patients with seizure disorder. 4.COPD patients with FEV1 5.Patients with psychiatric disorder. 6.Haemodynamically unstable patients including cardiac failure. 7.Heart rate 8.Patients with body weight more than 70kg. 9.Pregnancy and lactation. 10.Hypovolemia. 11.Oxygen Saturation

Design outcomes

Primary

MeasureTime frame
1.Composite score during the bronchoscopy procedure. 2.Numerical Rating Scale (NRS)for pain intensity and distress. 3.Visual Analogue Scale for cough. 4.Ease of bronchoscopy procedure. 5.Ramsay sedation score. 6.Post- procedure patient response after 24 hours.Timepoint: Prior, during, 10 mins after bronchoscopy and 24 hours after bronchoscopy—

Secondary

MeasureTime frame
1.Duration of Bronchoscopy procedure. 2.Number of doses of rescue medication required during the procedure. 3.Haemodynamic variables such as Heart rate (HR), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP). 4.Oxygen saturation 5.Lignocaine dose used. 6.Hypoventillation 7.Diagnostic procedures done during FB.Timepoint: Baseline, Start OF Flexible Bronchoscopy, 5 Minutes after the start of Bronchoscopy, 10 Minutes after start of Bronchoscopy, end of Bronchoscopy, 10 Minutes after end of Bronchoscopy.—

Countries

India

Contacts

Public ContactThomas Antony

Kasturba Medical college, Manipal

rahulmagazine@gmail.com9901727204

Outcome results

None listed

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