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临床试验/CTRI/2026/01/100592
CTRI/2026/01/100592尚未招募不适用

Towards better tolerability in awake endoscopy : A comparison of Lignocaine Lozenges and spray as topical anesthetic

Mmi Narayana multispeciality Hospital, Raipur1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1

研究概览

简要总结

Upper Gastro Intestinal Endoscopy (UGIE) is a critical tool in gastroenterology for screening, diagnosing and treating digestive disorders. Lignocaine has always been used for topical anesthesia, as it efficiently decreases cough reflex, gag reflex and airway hyper-reactivity during instrumentation of oral and pharyngeal cavity. Also, easy availability, cost effectiveness and ease of administration make it a logical choice. This is usually done by administration of a spray, gargle, viscous or nebulized forms that has a bitter taste that is repulsive. Improper dosing and gargling methods might lead to variable dosing and variable levels of anesthesia that might leave a bad experience for the patient and the operator. Additionally, the spray can lead to sore throat, hoarseness of voice and dysphagia. However, upto 40% of patients experience significant discomfort due to a strong gag reflexand a bitter taste of spray, which can hinder scope insertion and maneuvering. Additionally, they can evoke cardiopulmonary complications in the form of arrhythmias, myocardial ischemia, aspiration and hypoxia.To mitigate these issues, UGI Endoscopies are performed with topical pharyngeal anesthesia, with occasional intravenous sedation. Various formulations like viscous solution, gel, inhaler, popsicles and nebulized forms have been used extensively and evaluated for efficacy.

Lignocaine when used as a lozenge is promising but fewer studies have evaluated their efficacy and safety profile to conventional methods. Lignocaine lozenges have been introduced recently and is purported to offer better experience during UGIE. The advantage of a single dose, solid lozenge that is sucked and dissolved in saliva with advantages of multi-directional delivery to oral and pharyngeal mucosa over an extended contact time. It offers easy administration, better taste and compliance, thereby improving drug delivery.

This study aims to investigate Lignocaine lozenges as a superior topical anesthetic for UGIE, by comparing their effectiveness with 10% Lignocaine spray in reducing patients discomfort and facilitating ease of insertion and manipulation during procedures. The data thus collected will address gaps in current practices while evaluating differences in application methods and adverse effects. Establishing Lignocaine lozenges as a viable alternate could enhance patients comfort, improve procedural efficiency and decrease the need for sedation while advancing standard of care in UGIE.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for upper gastrointestinal endoscopy.
  • ASA I AND II.

排除标准

  • Refusal of consent ASA III AND IV Patient with psychological and neurological disorders.
  • History of allery to LA.
  • Known or suspected head and neck cancer.
  • Airway abnormalities.
  • Pregnant or lactating female.
  • Psychiatric disorders.
  • Neuromuscular disorders.
  • Emergency cases.
  • Critically ill patients.

研究者

发起方
Mmi Narayana multispeciality Hospital, Raipur
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Jyoti Sahu

NHMMI Narayana Multispeciality Hospital Raipur

研究点 (1)

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