| CTRI Number |
CTRI/2025/07/090317 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of nebulized ropivacaine 0.5% with nebulized lignocaine 2% on changes in the mean arterial pressure on intubation in patients undergoing surgery under general anaesthesia: A comparative randomized controlled study. |
|
Scientific Title of Study
|
Comparison of nebulized ropivacaine 0.5 percent with nebulized lignocaine 2 percent on the mean arterial pressure on intubation in patients undergoing surgery under general anaesthesia: A comparative randomized controlled 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 Sarita Janweja |
| Designation |
Senior professor , Department of Anesthesia |
| Affiliation |
Dr SN Medical college Jodhpur |
| Address |
Department of Anesthesia, Dr SN Medical college , Jodhpur Rajasthan 342003
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
sarita.janweja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Janweja |
| Designation |
Senior professor , Department of Anesthesia |
| Affiliation |
Dr SN Medical college Jodhpur |
| Address |
Department of Anesthesia, Dr SN Medical college , Jodhpur Rajasthan 342003
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
sarita.janweja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shravya M |
| Designation |
Postgraduate student |
| Affiliation |
Dr SN Medical college Jodhpur |
| Address |
Room no 83 pg girls hostel no 3 inside mdm campus gate 4 , Jodhpur Rajasthan 342003
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8746964247 |
| Fax |
|
| Email |
shravyam17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN medical college, Department of Anesthesia, Shastri nagar , Jodhpur Rajasthan India 342003. |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical college,Jodhpur |
| Address |
Dr SN Medical college, Jodhpur Rajasthan 342003 |
| Type of Sponsor |
Government 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 |
| Shravya M |
Mdm hospital |
Department of Anesthesia surgery ot 1 and 2 mdm hospital sector H Shastri nagar Jodhpur 342003
Jodhpur
RAJASTHAN |
8746964247
shravyam17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr SN medical college Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulised Lignocaine 2% |
Nebulised Lignocaine 2% of volume 5ml by nebuliser mask at 10L per minute oxygen flow |
| Comparator Agent |
Nebulised normal saline 0.9% |
Nebulised normal saline 0.9% of volume 5ml by nebuliser mask at 10L per minute oxygen flow |
| Intervention |
Nebulised Ropivacaine 0.5% |
Nebulised Ropivacaine 0.5% of volume 5ml by nebuliser mask at 10L per minute oxygen flow |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Classification (ASA) of 1 or II, aged 18-60 years, scheduled for elective surgeries under general anesthesia. |
|
| ExclusionCriteria |
| Details |
mental illness
allergies to relevant drug
anticipated difficult airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing between 2 groups the changes in mean arterial pressure on intubation in patients undergoing sure grey under general anesthesia which inturn assess the sympathetic response to intubation. |
Baseline before the procedure of nebulization
After nebulization.
Before tracheal intubation.
After tracheal intubation
4-5 minutes after tracheal intubation
At the closure of skin incision
Immediately after tracheal extubation
7-5 minutes after tracheal extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the changes in heart rate between 2 groups on intubation |
TO baseline before the procedure of nebulization
Tl after nebulization
T2 before tracheal intubation
T3after tracheal intubation
T4-5 minutes after tracheal intubation
TS at the closure of skin incision
T6 immediately after tracheal extubation
T7-5 minutes after tracheal extubation |
| Compare the cough response between 2 groups |
During extubation |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 4 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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="0"
Months="1"
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
|
Comparison of nebulized ropivacaine 0.5%with nebulized lignocaine 2% on the mean arterial pressure MAP on intubation in patients undergoing surgery under general anesthesia . It is a randomised controlled trial.The aim of this study to compare the efficacy of nebulized ropivacaine 0.5% and nebulized lignocaine 2% in attenuating mean arterial pressure on laryngoscopy and intubation. Time intervals being TO baseline before the procedure of nebulization Tl after nebulization T2 before tracheal intubation T3 after tracheal intubation T4 5 minutes after tracheal intubation TS at the closure of skin incision T6 immediately after tracheal extubation T7 after tracheal extubation . And also to compare heart rate at same time interval as MAP and the cough response at the time of extubation. |