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The effect of the drug dexmedetomidine in nebulized form in bronchoscopy as a pre-medication

Effectiveness of nebulized dexmedetomidine for premedication in flexible bronchoscopy in Indian patients- a prospective, randomized, double blinded study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040799
Enrollment
60
Registered
2022-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: J470- Bronchiectasis with acute lower respiratory infection

Interventions

Intervention1: Nebulized Dexmedetomidine: Dexmedetomidine at a dose of 1mcg/Kg diluted with 0.9% saline to make up to 5ml for nebulization. As the drug is given via nebulizer, it takes 10 minutes to a

Sponsors

Kasturba Medical college
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: a. Patients with known or suspected allergy to lignocaine or Dexmedetomidine b. Patients with renal or hepatic insufficiency c. Patients with seizure disorder d. COPD patients with FEV1 e. Patients with psychiatric disorder f. Hemodynamically unstable patients including cardiac failure g. Heart rate h. Patients with body weight more than 70kg. i. Pregnancy and lactation j. Patients posted for bronchoscopy and not consenting for study. h. Patients with nasal abnormalitues/infectionn

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 (VAS) for cough. 4. Ramsay sedation score (RSS). 5. Ease of bronchoscopy procedure as assessed by Observer B Timepoint: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. Patient is assessed 2 hours post procedure for other variables. Theres no follow up required for the study.—

Secondary

MeasureTime frame
1. Willingness for repeatability of the procedure as felt by patient. 2. Variations in heart rate (HR), blood pressure (BP), oxygen saturation (SpO2). 3. Duration of bronchoscopy procedure 4. Procedures underwent during bronchoscopy (Bronchial washing, broncho-alveolar lavage (BAL), bronchial brushing, endobronchial biopsy, transbronchial needle aspiration (TBNA), or transbronchial lung biopsy (TBLB)Timepoint: 0,1year—

Countries

India

Contacts

Public ContactPreetam Acharya

Manipal Academy of Higher Education

t.antony5@gmail.com8547437931

Outcome results

None listed

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