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CTRI Number  CTRI/2026/01/100592 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of local anesthesia delivery methods: Spray versus Lozenge for upper gastro intestinal endoscopy procedures. 
Scientific Title of Study   Towards better tolerability in awake endoscopy : A comparison of Lignocaine Lozenges and spray as topical anesthetic 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Sahu 
Designation  DNB Resident 
Affiliation  NHMMI Narayana Multispeciality Hospital Raipur 
Address  2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India 
Phone  09340443104  
Fax    
Email  sahujyoti042@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh R Chand 
Designation  Head of Department, Anaesthesiology 
Affiliation  NHMMI Narayana Multispeciality Hospital Raipur 
Address  2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India 
Phone  8697016606  
Fax    
Email  rakeshrajkumar.dr@narayanahealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Rakesh R Chand 
Designation  Head of Department, Anaesthesiology 
Affiliation  NHMMI Narayana Multispeciality Hospital Raipur 
Address  2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
2nd Floor, B Block, OT Complex, Anaesthesia department NHMMI Narayana Multispeciality Hospital, Dhamtari Road, Pachpedi Naka Rd, Lalpur, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India 
Phone  8697016606  
Fax    
Email  rakeshrajkumar.dr@narayanahealth.org  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mmi Narayana multispeciality Hospital, Raipur 
Address  NHMMI Narayana Multispeciality Hospital, Dhamtari Road , Lalpur, Raipur 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoti Sahu  NHMMI Narayana Multispeciality Hospital  Endoscopy Room, 2nd Floor, OT Complex, B Block, Anaesthesia Department
Raipur
CHHATTISGARH 
09340443104

sahujyoti042@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients posted for upper gastrointestinal endoscopy.
ASA I AND II 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain, anxiety, gag reflex and patient satisfaction  15 min 
 
Secondary Outcome  
Outcome  TimePoints 
Endoscopist satisfaction, Ease of instrumentation  15 min 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 reflex and 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.

 

 

 
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