| CTRI Number |
CTRI/2022/09/045630 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/03/2023 |
| 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
|
A comparative study of 2% lignocaine nebulization with 0.5% ropivacaine nebulization for controlling blood pressure and heart rate during intubation and extubation after general anaesthesia |
|
Scientific Title of Study
|
A comparative study of 2% lignocaine nebulization with 0.5% ropivacaine nebulization for attenuation of haemodynamic responses to endotracheal intubation and extubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balasai Gorrela |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology,
Goa Medical College
Bambolim,
Goa
Department of Anesthesiology,
Goa Medical College,
Bambolim,
Goa
North Goa
GOA
403201
India |
| Phone |
8885886619 |
| Fax |
|
| Email |
balasaig1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila G Borkar |
| Designation |
Associate Professor |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology,
Goa Medical College
Bambolim,
Goa
Department of Anesthesiology,
Goa Medical College
Bambolim,
Goa
North Goa
GOA
403201
India |
| Phone |
|
| Fax |
|
| Email |
drsharmila_borkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila G Borkar |
| Designation |
Associate Professor |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology,
Goa Medical College
Bambolim,
Goa
Department of Anesthesiology,
Goa Medical College
Bambolim,
Goa
North Goa
GOA
403201
India |
| Phone |
|
| Fax |
|
| Email |
drsharmila_borkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital ,Bambolim,Goa |
|
|
Primary Sponsor
|
| Name |
Goa Medical College and Hospital |
| Address |
Goa Medical College and Hospital,
Bambolim,
Goa |
| 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 |
| Balasai Gorrela |
Goa Medical College and Hospital, Operation Theatre(Lower and Upper OT) |
Trial/Procedure will be conducted in Upper and Lower Operation Theatre as per the cases posted for surgeries requiring General Anesthesia
Department of Anesthesiology
Goa Medical College
Bambolim
North Goa
403201
North Goa
GOA |
8885886619
balasaig1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA MEDICAL COLLEGE BAMBOLIM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% ropivacaine nebulization |
The effect of 0.5% ropivacaine nebulization given for 10 minutes duration before induction for attenuation of haemodynamic responses to endotracheal intubation and extubation will be studied |
| Intervention |
2% lignocaine nebulization |
The effect of 2% lignocaine nebulization given for 10 minutes duration before induction for attenuation of haemodynamic responses to endotracheal intubation and extubation will be studied |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients |
|
| ExclusionCriteria |
| Details |
1.Patient Refusal
2.Obstetric patients
3.Known allergy to drugs involved in the study
4.Patients with clinical evidence of difficult airway
5.Emergency surgical procedures with full stomach requiring RSI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 2% lignocaine with 0.5% ropivacaine 5ml nebulization ,in attenuation of haemodynamic responses during endotracheal intubation and extubation |
At Baseline
Before Laryngoscopy and intubation
Immediately after Laryngoscopy and intubation
Every 1 minute for next 5 minutes
10 minutes after intubation
Upon anaesthetic withdrawal
Upon eye opening on verbal command
Upon tracheal extubation
Two minutes after extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate cough response and haemodynamics during extubation with airway topicalization |
severity of cough and haemodynamic parameters at the time of extubation are studied |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to evaluate the effectiveness of local anesthetic nebulization for attenuation of haemodynamic responses during endotracheal intubation and and extubation and to enhance the quality of clinical care during these procedures |