An Open Label, Comparative, multicentric study to evaluate efficacy and safety of lidocaine lozenges vs local lidocaine spray in patients scheduled for diagnostic Laryngoscopy and/or punch biopsy of upper aero-digestive tract.

Troikaa Pharmaceuticals Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1.Patients of either sex aged 18-80 years.
•2.Patients undergoing diagnostic laryngoscopy and/or punch biopsy of upper aero-digestive tract.
•3.American Society of Anesthesiologist (ASA) Physical status I and II of patients.

•1.History of hypersensitivity to amide type lidocaine anesthetics or any component of the formulation
•2.Patients with medical history of respiratory disease such as asthma, bronchitis or chronic obstructive pulmonary disease.
•3.Use of another topical product at application site
•4.Expecting unusual surgical difficulty
•5.Unwilling patients.
•6.Emergency surgery/ surgery needing hospitalization
•7.Clinically significant impairment of hepatic/renal/cardiac functions
•8.Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study
•9.Pregnant women and lactating mothers
•10.Women of child bearing age not practicing contraception
•11.Participation in a clinical study involving an investigational product within past 30 days
•12.Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).

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