| 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
|
|
|
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
|
|
|
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
|
|
|
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. |