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Comparison between Midazolam and Dexmedetomidine in bronchoscopy

Comparison between intravenous Midazolam and intravenous Dexmedetomidine in flexible bronchoscopy- A prospective, randomized, double blinded study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/009969
Enrollment
54
Registered
2017-10-03
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.

Interventions

Intervention1: MIDAZOLAM: Patients in Group A will recieve Normal Saline/Midazolam 0.035 mg/kg Control Intervention1: DEXMEDETOMIDINE: Patients in group B will recieve Dexmedetomidine 0.5 µg/kg /Nor

Sponsors

Kasturba Medical College Manipal
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

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 24hours.Timepoint: Prior, during, 10mins after bronchoscopy and 24hours 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 , systolic blood pressure, and diastolic blood pressure 4.Oxygen saturation . 5.Lignocaine dose used Timepoint: BASELINE,START OF FB,5 MINUTES AFTER THE START OF FB,10 MINUTES AFTER THE START OF FB,END OF FB,10 MINUTES AFTER THE END OF FB.

Countries

India

Contacts

Public ContactDR RAHUL MAGAZINE

KASTURBA MEDICAL COLLEGE, MANIPAL

rahulmagazine@gmail.com9686676567

Outcome results

None listed

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