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

Not yet recruiting

• Conditions: Bronchiectasis with acute lower respiratory infection,

• Registration Number: CTRI/2022/03/040799
• Lead Sponsor: Kasturba Medical college

Brief Summary

A written informed consent will be taken from all study participants. For patients who meet the inclusion criteria, demographic details like age, gender, height, weight, BMI, prior bronchoscopy procedure, current indication for bronchoscopy and the procedures done during bronchoscopy will be recorded in the study proforma.

Patients undergoing FB will be randomized in a one is to one ratio as per a computer generated randomization table and will be allocated to any of the two groups (Group **A** or Group **B**).

Patients in group **A** will receive nebulized dexmedetomidine at 1 mcg/Kg, diluted with 0.9% saline into 5 ml. Patients in group **B** receive 5 ml of 0.9% saline nebulization prior to bronchoscopy. A composite scoring will be done by observer C at the level of nasopharynx, during passage through trachea and when crossing the carina. Heart rate, cardiac rhythm. Non-invasive blood pressure (NIBP), respiratory rate, and pulse oximetry saturation will be recorded before the start of bronchoscopy, monitored continuously during the procedure till its completion and 10 minutes post procedure. Patient is further assessed after 24 hours and asked to give their opinion on the procedure, the quality of sedation, discomfort, any adjustment needed in the dose of sedation and willingness for a repeat procedure if required

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-03
• Study Start: 2022-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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 <50% e.Patients with psychiatric disorder f.Hemodynamically unstable patients including cardiac failure g.Heart rate <50 beats per min or second or third degree heart block h.Patients with body weight more than 70kg.
• i.Pregnancy and lactation j.Patients posted for bronchoscopy and not consenting for study.
• Patients with nasal abnormalitues/infectionn.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Composite score during the bronchoscopy procedure.	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.
2.Numerical Rating Scale (NRS) for pain intensity and distress.	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.
3.Visual Analogue Scale (VAS) for cough.	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.
4.Ramsay sedation score (RSS).	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.
5.Ease of bronchoscopy procedure as assessed by Observer B	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 Outcome Measures

Name	Time	Method
1.Willingness for repeatability of the procedure as felt by patient.	2.Variations in heart rate (HR), blood pressure (BP), oxygen saturation (SpO2).

Trial Locations

Locations (1)

Kasturba Medical College; 🇮🇳 Kannada, KARNATAKA, India

Kasturba Medical College

🇮🇳Kannada, KARNATAKA, India

Dr Thomas Antony

Principal investigator

8547437931

t.antony5@gmail.com