| CTRI Number |
CTRI/2026/03/106450 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two anaesthetics for Easing Intubation and Sore Throat After Surgery |
|
Scientific Title of Study
|
COMPARATIVE ANALYSIS OF NEBULIZED ROPIVACAINE (0.75%) WITH NEBULIZED LIGNOCAINE (2%) ON ATTENUATION OF INTUBATION RESPONSE AND POST OPERATIVE SORE THROAT:A RANDOMIZED DOUBLE BLIND STUDY |
| 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 Ambika Singh |
| Designation |
Post Graduate |
| Affiliation |
Ananta Institute of Medical Sciences and Research Center |
| Address |
PG Hostel,Ananta Institute Campus, kaliwas, Delwara
Ananta Institute of Medical Sciences and Research Centre, kaliawas, Delwara, Rajsamand, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9636088914 |
| Fax |
|
| Email |
ambikas160@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Thakore |
| Designation |
Associate Professor |
| Affiliation |
Ananta Institute of Medical Sciences and Research Center |
| Address |
Room No.2041, 2nd Floor,OT Complex,Department of Anaesthesia,Ananta Institute of Medical Sciences
Ananta Institute of Medical Sciences and Research Centre, kaliawas, Delwara, Rajsamand, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
09571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Thakore |
| Designation |
Associate Professor |
| Affiliation |
Ananta Institute of Medical Sciences and Research Center |
| Address |
Room No.2041, 2nd Floor,OT Complex,Department of Anaesthesia,Ananta Institute of Medical Sciences
Ananta Institute of Medical Sciences and Research Centre, kaliawas, Delwara, Rajsamand, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
09571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ananta Institute of Medical Sciences and Research Centre |
| Address |
Ananta Institue Campus,Village Kaliwas,NH-8,Near Udaipur,Rajsamand,Rajasthan,India,pincode 313202 |
| Type of Sponsor |
Private medical college |
|
|
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 Sakshi Thakore |
Ananta Institute of Medical Sciences and Research Centre |
Room no. 2041, OT Complex, 2nd floor Ananta Institute Campus, kaliawas,NH-8,Near Udaipur,Rajsamand- 313202
Udaipur
RAJASTHAN |
09571241824
drsakshiarora88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Ananta Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H95||Intraoperative and postproceduralcomplications and disorders of ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine |
Group L will receive nebulized Lignocaine 2%, 5 mL, administered 15 minutes prior to induction of general anesthesia. Nebulization is done via face mask using 100% oxygen at 10 L/min until the drug is aerosolized. |
| Intervention |
Ropivacaine |
Group R will receive nebulized Ropivacaine 0.75%, 5 mL, administered 15 minutes prior to induction of general anesthesia. Nebulization is done via face mask using 100% oxygen at 10 L/min until the drug is aerosolized. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I and II
2.Scheduled for elective surgery under general anaesthesia
3.Provided written informed consent |
|
| ExclusionCriteria |
| Details |
1. ASA Grade III and IV
2. History of cardiovascular disease
3.BMI less than 20 or more than 30
4.Pregnancy or Lactation
5.Allery to local anaesthetics
6. Anticipated difficult airway
7.Duration of surgery more than 3hrs
8.Surgical complications (e.g.,dura puncture,bleeding) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Changes in Heart Rate,Blood Pressure (MAP)during intubation between two groups |
T0 - baseline before nebulization
T1 - after nebulization
T2 - before laryngoscopy
T3 - 1 minutes after laryngoscopy
T4 -3 minutes after intubation
T5 - 5 minutes after tracheal intubation
T6 – 7 minutes after tracheal intubation
T7 - 10 minutes after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Severity of Postoperative sore throat (POST)
2.Incidence and Severity of cough during extubation |
1.0,2,4,6,12 and 24 hours post extubation
2.Immediately, 30 min and 1 hour after extubation
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-12-2027 and end date provided 30-12-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective, randomized, double-blind clinical study compares nebulized ropivacaine(0.75%) with lignocaine (2%) for attenuating haemodynamic responses during intubation and reducing postoperative sore throat in patients undergoing general anaesthesia.Sixty patients aged 18-65 years (ASA I/II) will be enrolled and randomly assigned to either group.Hemodynamic parameters (HR,BP,MAP),incidence of cough and severity of sore throat will be assessed at predefined time points.The study aims to identify the more effective agent for improving patient comfort and stability during airway management. |