| CTRI Number |
CTRI/2020/07/026563 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Topical Aerosolized Ropivacaine(0.75%)on Response To Extubation
|
|
Scientific Title of Study
|
Effect Of Topical Aerosolized Ropivacaine (0.75%) On Response To Extubation InAdults
Patients Requiring General Anaesthesia For Elective Surgical Procedures : Randomized
Controlled Trial
|
| Trial Acronym |
TAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNaresh Yerne |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College;Nagpur |
| Address |
Department of Anaesthesia
1st floar government medical college; NAGPUR
Mard hostel room no:70
Gmc nagpur
Medical square
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9404212734 |
| Fax |
|
| Email |
dr.naresh08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjali Savargaonkar |
| Designation |
Professor ; Department of Anaesthesiology |
| Affiliation |
Government Medical College;Nagpur |
| Address |
OTE
GOVERNMENT MEDICAL COLLEGE NAGPUR
Nagpur
MAHARASHTRA
440013
India |
| Phone |
9527002761 |
| Fax |
|
| Email |
anj123sg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnjali Savargaonkar |
| Designation |
Professor ; Department of Anaesthesiology |
| Affiliation |
Government Medical College;Nagpur |
| Address |
OTE
GOVERNMENT MEDICAL COLLEGE NAGPUR
Nagpur
MAHARASHTRA
440013
India |
| Phone |
9527002761 |
| Fax |
|
| Email |
anj123sg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored with support from bospital |
|
|
Primary Sponsor
|
| Name |
DrNaresh Yerne |
| Address |
At post paraswada
Tq tiroda dist gondia
441911 |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 |
| Naresh |
OTE, 1st floarGovernment Medical college and Hospital ;Nagpur |
Operation theatre E, 1st floar
Government medical college nagpur
Medical square 440013
Nagpur
MAHARASHTRA |
9404212734
dr.naresh08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Medical College,Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atomization |
Atomization of ropivacaine 0.75% 6 ml over glottis with atomizer instrument. |
| Comparator Agent |
Compare |
Compare the response of drug with normal saline 6 ml by using atomizer on Response to extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS I or II schedule, for elective surgery under general anaesthesia requiring oral endotracheal intubation with the clinically normal airway. |
|
| ExclusionCriteria |
| Details |
Severe cardiovascular, liver, and kidney disfunction;
Allergies to amide local anesthetics;
Patient with history of risk factor for perioperative aspiration of gastric ontents
Difficult airway or history of maxillofacial and neck surgery;
Chronic respiratory disease such as chronic obstructive pulmonary disease or asthma, recent respiratory tract infection, chronic cough, and current smoking.
Patients with reoperation because of serious adverse events such as bleeding,
Anesthesia time more than 4 h, and delayed extubation (more than 1 h without extubation)
Prolong surgery (more than 3 hr)
Transferd to the Intensive Care Unit (ICU) with the tube were eliminated.
Medications invoving angiotensin converting enzyme inhibitor
Refusal to participate in study |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic response(Mean arterial pressure & HeartRate)toextubation;
&
2.Cough occurring at extubation.
|
Will be assesed at extubation
After 2 min
After 5 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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 1 |
|
Date of First Enrollment (India)
|
20/07/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ropivacaine has long-acting local anaesthetic and topical anaesthesia wit The ropivacaine been has reported to significantly attenuate histamine-induced.topical of ropivacaine(nebulisation, infiltration, atomization) reported to significantly reduce extubation response in a hypertensive patient. We will hypothesize that topical application inhibiting bit hemodynamic response cough reflex during extubation in operative patient under general anaesthesia. |