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Clinical Trials/CTRI/2025/08/093079
CTRI/2025/08/093079
Not yet recruiting
Not Applicable

Randomised comparative study between atomised intranasal dexmedetomidine , lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy

ESIC MEDICAL COLLEGE AND HOSPITAL1 site in 1 country60 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
ESIC MEDICAL COLLEGE AND HOSPITAL
Enrollment
60
Locations
1
Primary Endpoint
patient cough score

Overview

Brief Summary

the study aims to compare the effectiveness of  atomised intranasal demedetomedine, lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy. Primary objective is to evaluate the incidence of moderate to severe cough during the procedure. Secondary objective is to compare the patient satisfaction score, endoscopist satisfaction score, ramsay sedation score and if any rescue lignocaine required. ASA I & II patients of more than 18 years age with BMI less than 30 kg/m2 will be included and patients with history of bronchial asthma or allergy to the study drugs will be excluded. 60 patients will be randomly divided into 3 groups of 20 each. atomised ketamine (2mg/kg), atomised dexmedetomidine (2 mcg/kg) and atomised lignocaine (1.5 mg/kg) will be given as premedication 30 inutes prior to the procedure and the above mentioned objectives will be assessed. P values less than 0.05 will be considered significant.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I & II patients, age older than 18 years, BMI less than 30 kg/cm2.

Exclusion Criteria

  • ASA III & IV patients, history of bronchial asthma, history of allergy to the study drugs.

Outcomes

Primary Outcomes

patient cough score

Time Frame: baseline,immediately after passage of bronchoscope through vocal cords, at 5 and 10 minutes during the bronchoscopy procedure

Secondary Outcomes

  • patient satisfaction score(10 minutes after end of procedure)
  • ramsay sedation score(prior to procedure, 10 minutes after end of proceure)
  • endoscopists satisfaction score(after end of procedure)
  • rescue lignocaine required(during procedure)

Investigators

Sponsor
ESIC MEDICAL COLLEGE AND HOSPITAL
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Prerna Bhola

ESIC MEDICAL COLLEGE

Study Sites (1)

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