The comparison of effectiveness and safety of two different doses of aerosolized sedative dexmeditomidine to local anaesthetic agent lignocaine for conducting flexible fiberoptic bronchoscopy for purpose of diagnosis

Safety and efficacy of two different doses of nebulized dexmeditomidine as an add on to lignocaine for premedication during diagnostic awake flexible fiberoptic bronchoscopy : A randomized trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042057

Enrollment

Registered

2022-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: nebulized 0.6 mcg/kg dexmeditomidine: 0.6 mcg/kg dose of dexmeditomidine will be added to 1 ml of 2 % lignocaine to make atotal volume of 4 ml using isotonic normal saline for nebuliz

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) Physical Status I/ II patients 2. Age between 18 years to 65 years scheduled for an elective bronchoscopy procedure. 3. Patients willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Intubated patients 2. Inability to maintain oxygen saturation (SpO2 3. History of bleeding diathesis 4. Known case of heart block 5. History of Anaphylaxis to any of the drugs

Design outcomes

Primary

Measure	Time frame
To compare the cough reflexes scores during diagnostic awake flexible fiberoptic bronchoscopy in patients treated with 0.6 and 1 mcg/kg doses of dexmeditomidine and placebo as an adjuvant to 2% lignocaine. Timepoint: From introduction of fiberoptic bronchoscope into the nostril of the patient till 60 minutes	—

Secondary

Measure	Time frame
Any adverse events Timepoint: From initiation of nebulization of the mixture to 120 minutes after end of the procedure of awake fiberoptic bronchoscopy;hemodynamic profile (heart rate and MAP) Timepoint: From initiation of nebulization of the mixture to 60 minutes after end of the procedure of awake fiberoptic bronchoscopy;immediate post procedure RSS Timepoint: At the end of the procedure of awake fiberoptic bronchoscopy;level of sedation achieved using pre procedure Ramsay sedation scale (RSS) prior to the intravenous sedation protocol Timepoint: From initiation of nebulization of the mixture to 60 minutes after end of the procedure of awake fiberoptic bronchoscopy;patient satisfaction after 2 hours of diagnostic awake flexible fiberoptic bronchoscopy Timepoint: From initiation of nebulization of the mixture to 120 minutes after end of the procedure of awake fiberoptic bronchoscopy;the need for rescue sedation Timepoint: From the end of the nebulization of the mixture to to the end of the procedure of awake fiberoptic bronchoscopy;total lignocaine dose used. Timepoint: From initiation of nebulization of the mixture to the end of the procedure of awake fiberoptic bronchoscopy	—

Measure

Time frame

Any adverse events Timepoint: From initiation of nebulization of the mixture to 120 minutes after end of the procedure of awake fiberoptic bronchoscopy;hemodynamic profile (heart rate and MAP) Timepoint: From initiation of nebulization of the mixture to 60 minutes after end of the procedure of awake fiberoptic bronchoscopy;immediate post procedure RSS Timepoint: At the end of the procedure of awake fiberoptic bronchoscopy;level of sedation achieved using pre procedure Ramsay sedation scale (RSS) prior to the intravenous sedation protocol Timepoint: From initiation of nebulization of the mixture to 60 minutes after end of the procedure of awake fiberoptic bronchoscopy;patient satisfaction after 2 hours of diagnostic awake flexible fiberoptic bronchoscopy Timepoint: From initiation of nebulization of the mixture to 120 minutes after end of the procedure of awake fiberoptic bronchoscopy;the need for rescue sedation Timepoint: From the end of the nebulization of the mixture to to the end of the procedure of awake fiberoptic bronchoscopy;total lignocaine dose used. Timepoint: From initiation of nebulization of the mixture to the end of the procedure of awake fiberoptic bronchoscopy

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Countries

India

Contacts

Public ContactAnkita Kabi

AIIMS Gorakhpur

ankitakabi@yahoo.com

Outcome results

None listed

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