| CTRI Number |
CTRI/2025/11/097492 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of local anaesthesia medicine as steam on heart during nose operations. |
|
Scientific Title of Study
|
A randomized comparative clinical trial to study the effect of 4 percent lignocaine nebulization and 10 percent lignocaine spray on intraoperative hemodynamics for intranasal surgeries under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Domala Radhika |
| Designation |
Assisstant professor |
| Affiliation |
esic medical college |
| Address |
Room number 3021, anaesthesia department, 3rd floor , esic medical college,hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
9505032812 |
| Fax |
|
| Email |
domalaradhika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Domala Radhika |
| Designation |
Assisstant professor |
| Affiliation |
esic medical college |
| Address |
Room number 3021, anaesthesia department, 3rd floor , esic medical college,hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9505032812 |
| Fax |
|
| Email |
domalaradhika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Domala Radhika |
| Designation |
Assisstant professor |
| Affiliation |
esic medical college |
| Address |
Room number 3021, anaesthesia department, 3rd floor , esic medical college,hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
9505032812 |
| Fax |
|
| Email |
domalaradhika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Esic medical college,hyderabad, Room number 3021, anaesthesia department, 3rd floor . 500038 |
|
|
Primary Sponsor
|
| Name |
esic medical college |
| Address |
Room number 3021, anaesthesia department, 3rd floor , esic medical college,hyderabad 500038 |
| 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 |
| Domala radhika |
Operation theatre complex ,3rd floor |
Room number 3021, anaesthesia department, 3rd floor , esic medical college,hyderabad.
Hyderabad
TELANGANA |
9505032812
domalaradhika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC medical college and hospital and ESIC superspeciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, (2) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9 percent normal saline |
patients receive 0.9 percent normal saline 2.5ml via nebulisation 15 minutes before induction in the pre operative area . |
| Intervention |
10 percent lignocaine spray |
patients receive 5 puffs of 10 percent topical lignocaine spray in each nostril at 2mg/kg (10mg per puff) 15 minutes before induction in the preoperative area |
| Intervention |
4 percent lignocaine nebulization |
Patients receive 4 percent lignocaine hydrochloride through nebulization at 2mg/kg (2.5ml containing 100mg for a patient with 50kg weight)given 15 min before induction in the preoperative area |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologists 1,2.
valid written informed consent
patient undergoing intranasal surgeries.
|
|
| ExclusionCriteria |
| Details |
American society of Anesthesiologists 3,4
drug allergies
bleeding disorders
patient refusal
pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Heart rate (HR) and Mean arterial pressure (MAP). |
o,5,15,30,45,60,90,120,150 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare surgical field score, post operative analgesia. |
0,4,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 Applicable |
| 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
|
Intranasal surgeries encompass a diverge range of procedures performed within nasal cavity to address structural ,funtional or pathological conditions .These surgeries including septoplasty ,endoscopic sinus surgery and turbinate reduction are integral in managing conditions such as chronic rhinosinusitis ,nasal obstruction ,deviated nasal septum .It is essential to provide adequate pain management in patients who undergo intranasal surgery. Due to the great vascularity of the nasal mucosa the main concern with intranasal surgeries is intranasal bleeding compromising visibility of surgical field which may further lead to damage of vascular structures, endoscope entering intracranial space ,entering into orbit ,increased duration of surgery ,major blood loss .Local anesthetics directly act on nasal mucosa and also block sphenopalatine ganglion so we planned a study to compare the intraoperative hemodynamics with 4 percent lignocaine nebulization and 10 percent lignocaine spray for intranasal surgeries under general anesthesia.
|