| CTRI Number |
CTRI/2022/09/045292 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Effect of Airway Nebulization with 2% Lignocaine,nebulised 1mcg/kg dexmedetomidine and 0.25%Ropivacaine on Intubation and Extubation Response in Patients Undergoing Surgery under General Anesthesia |
|
Scientific Title of Study
|
Comparison of Effect of Airway Nebulization with lignocaine 2% nebulized Dexmedetomidine and Ropivacaine 0.25% on Intubation and Extubation response in patients undergoing surgery under general Anaesthesia: A Randomized Double Blind clinical trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
E Lavanya |
| Designation |
associate professor |
| Affiliation |
srilakshmi narayana institute of medical sciences |
| Address |
department of anesthesiology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09629181969 |
| Fax |
|
| Email |
dr.lavanya08@gmail.com |
|
|
Source of Monetary or Material Support
|
| srilakshmi narayana institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
srilakshmi narayana institute of medical sciences |
| Address |
pondicherry |
| 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 |
| elavanya |
srilakshmi narayana institute of medical sciences |
department of anesthesiology and critical care
Pondicherry
PONDICHERRY |
09629181969
dr.lavanya08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
asa status 1 and 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
Dexmedetomidine at a dose of 1 µg/kg (mixed with saline to a total volume of 5 ml) nebulisation was administered |
| Comparator Agent |
lignocaine |
5 ml of 2% lignocaine via nebulization |
| Comparator Agent |
ropivacaine |
5 ml of 0.25% ropivacaine nebulization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgery under general anesthesia with endotracheal intubation cases |
|
| ExclusionCriteria |
| Details |
ASA 3 or more
Patients with history of risk factors for perioperative aspiration of gastric contents,
history of chronic obstructive pulmonary disease, asthma,
history of recent respiratory infections,
duration of surgery more than 3 h were excluded from the study.
Pregnant and lactating mother
Anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| attenuation of intubation response |
MAP, HR, and SPO2 at;
Baseline (T1)
Upon tracheal intubation (T2)
Upon anesthetic withdrawal (T3)
Upon eye opening on verbal commands (T4)
Upon tracheal extubation (T5)
Two min after extubation (T6).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| extubation response |
up on end of surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/09/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Comparison of Effect of Airway Nebulization with Lignocaine 2%, nebulised dexmedetomidine 1mcg/kg and Ropivacaine 0.25% on Intubation and Extubation Response in Patients Undergoing Surgery under General Anesthesia: A Randomized Double’Blind Clinical Trial with Patient included from age 18-70 years of either sex posted for
Elective surgery under general anesthesia with endotracheal intubation patients randomised in to three groups using block randomization.Group 1: Received Dexmedetomidine at a dose of 1 µg/kg mixed with saline to a total volume of 5 ml nebulization • Group 2: Received 5 ml of 0.25% ropivacaine nebulization • Group 3: Received 5 ml of 2% lignocaine via nebulization. Drug was administered as aerosol through nebulization.MAP, HR, and SPO2 at; • Baseline (T1) • Upon tracheal intubation (T2) • Upon anesthetic withdrawal (T3) • Upon eye opening on verbal commands (T4) • Upon tracheal extubation (T5) • Two min after extubation (T6). were recorded and compared in this study General parameters i.e. Age, Gender, weight, height and Duration of surgery and duration of anesthesia.were compared and analysed.
|