| CTRI Number |
CTRI/2024/10/075432 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Ropivacaine and Lignocaine by nebulization on hemodynamic stress response during extubation in surgeries under General Anaesthesia |
|
Scientific Title of Study
|
Comparison of Ropivacaine with Lignocaine by Nebulization for hemodynamic stress response during Extubation in patients undergoing 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 |
Dr Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesia,
GGSMCH, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
Amritk_dr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesia,
GGSMCH, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
Amritk_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesia,
GGSMCH, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
Amritk_dr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Haramritpal Kaur |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvjeet Kaur |
Department of Anaesthesiology, GGSMCH, Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karan Garg |
Guru Gobind Singh Medical College and Hospital |
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB |
6239884909
gargkaran6366@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (3) ICD-10 Condition: K80||Cholelithiasis, (4) ICD-10 Condition: N63||Unspecified lump in breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine |
Lignocaine(2%) will be given by nebulization for 5-7 preoperatively for hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia |
| Intervention |
Ropivacaine |
Ropivacaine (0.75%) will be given by nebulization for 5-7 mins preoperatively for hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mallampati grade I and II
American Society of Anaesthesiologist grade I and II |
|
| ExclusionCriteria |
| Details |
Patients with a history of allergy to local anaesthetics/study drugs
Patients in whom intubation time exceeded 15 seconds or in those where second attempt for intubation was needed
Surgery duration more than 3 hrs |
|
|
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 study effect of ropivacaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia
To study effect of lignocaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia |
Till 15 mins of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of ropivacaine and lignocaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia |
Till 15 mins of extubation |
| To compare the effects of ropivacaine and lignocaine by nebulization on postoperative sore throat in patients undergoing surgeries under general anaesthesia |
Till 24 hours postoperative |
| To compare the effects of ropivacaine and lignocaine by nebulization on postoperative cough in patients undergoing surgeries under general anaesthesia |
Till 24 hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
Hemodynamic changes such as increase in Blood Pressure, Heart Rate during airway management is common and can be associated with severe cardiovascular and neurological complications in some patients. Intravenous Lignocaine is commonly used to attenuate this response. Nebulization with local anaesthetics is also an alternative. The techniques to suppress hemodynamic stress response include topical anaesthesia of oropharynx (viscous lignocaine) laryngotracheal instillation of lignocaine just prior to intubation, intravenous lignocaine, adrenergic blocking drugs (either alpha or beta blockers), vasodilators like hydrallazine, sodium nitroprusside, nitroglycerine, deep inhalational anaesthesia, intravenous opioids etc. However, no single agent has been established as the most appropriate for this purpose In present study, we propose to evaluate and compare two local anaesthetic nebulization that is Lignocaine (2%) and Ropivacaine (0.75%) for their effect on extubation stress response. We hypothesized that Ropivacaine being longer acting should be able to suppress the extubation response better than Lignocaine. |