| CTRI Number |
CTRI/2017/10/010254 [Registered on: 30/10/2017] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two drugs named lignocaine and ropivacaine on reducing the rise in blood pressure and heart rate that happens during begining of anaesthesia and at termination of anaesthesia. |
|
Scientific Title of Study
|
Comparison of effect of airway nebulisation with lignocaine 2% vs ropivacaine 0.25% on intubation and extubation response in patients undergoing surgery under general anaesthesia, A Randomised double blind clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ramyavel |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramyavel |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
ETC block, 2 nd floor,Department of anaesthesiology, Pondicherry institute of medical sciences,Ganapathichettikulam,kalapet,puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramyavel |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Room No.3, ETC block, 2nd floor, Department of Anaesthesiology, Pondicherry institute of medical sciences,Ganapathichettikulam,kalapet,puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramyavel |
| Designation |
Assistant professor |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
Room No 3, ETC block, 2 nd floor, Department of anaesthesiology, Pondicherry institute of medical sciences,Ganapathichettikulam,kalapet,puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry institute of medical sciences, Ganapathichettikulam,kalapet, puducherry 605014 |
|
|
Primary Sponsor
|
| Name |
Dr Ramyavel |
| Address |
NO 3c, sarathy enclave, rajaji nagar, lawspet, puducherry |
| Type of Sponsor |
Other [primary investigator] |
|
|
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 Ramyavel |
Pondicherry institute of Medical sciences |
2nd floor,department of anaesthesiology,ETC block,PIMS,puducherry
Pondicherry
PONDICHERRY |
9487630425
ramyavel1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pondicherry institute of medical sciences ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA 1 and ASA 2 patients posted for surgery under general anaesthesia, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine 2% |
Lignocaine 2% will be given via nebulisation pre induction.Lignocaine is a class of local anaesthetic. |
| Intervention |
Ropivacaine 0.25% |
Ropivacaine 0.25% will be given via nebulisation prior to induction.Ropivacaine is a class of local anaesthetic drug. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 Patients posted for surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1) duration of surgery >3 hours.
2) surgery involving the airway.
3) patients with history of respiratory disease or LRI.
4) >3 attempts at laryngoscopy or intubation. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters ( Heart rate, Mearn arterial Pressure and saturation) at the time of intubation and extubation. |
MAP, HR, and Spo2 at;
A)Baseline (T1)
B)Upon tracheal intubation (T2)
C)Upon anaesthetic withdrawal (T3)
D)Upon eye opening on verbal commands (T4)
E)Upon tracheal extubation (T5)
F)2 min after extubation (T6)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) severity of cough at extubation
2) time to extubation |
1)Upon tracheal extubation (T5).
2)Time from stopping inhalational agent till removal of tube.(in min) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2017 |
| Date of Study Completion (India) |
10/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Both intubation and extubation is associated with hemodynamic changes . To reduce this response we aimed at using local anaesthetics i.e. ropivacaine 0.25% and lignocaine 2% topically .Both the drugs will be given via nebulisation prior to induction. After IEC approval 60 patients of age group 18 to 60 years belonging to ASA 1 and ASA 2 undergoing surgery under general anaesthesia will be enrolled in the double blind study.About 20 min before induction, patients will be given either of the drug via nebulisation. Anaesthesia induction and intubation and extubation will be according to standard protocol. Hemodynamic parameters ie HR, MAP and spo2 will be recorded at various time points. Severity of cough and time to extubation will also be recorded. |