| CTRI Number |
CTRI/2024/11/077212 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study to assess the stress response of the patient for removing endotracheal tube by using two types of drugs |
|
Scientific Title of Study
|
A prospective randomised controlled comparative clinical study of attenuation of hemodynamic responses to endotracheal extubation using lignocaine and combination of lignocaine and diltiazem |
| 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 SEENIVASAN V |
| Designation |
Post graduate, Anaesthesiology |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Anaesthesia - Mysore medical college and research institute
1st floor , New stone building
KR Hospital , Irwin road
Mysore
Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9095763387 |
| Fax |
|
| Email |
seenilav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H G Manjunath |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Anaesthesia - Mysore medical college and research institute
1st floor , New stone building
KR Hospital , Irwin road
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9448054368 |
| Fax |
|
| Email |
drhgmanjunath@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SEENIVASAN V |
| Designation |
Post graduate, Anaesthesiology |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Anaesthesia - Mysore medical college and research institute
1st floor , New stone building
KR Hospital , Irwin road
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9095763387 |
| Fax |
|
| Email |
seenilav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical college and research institute, KR Hospital, Irwin road, Mysore 570001 |
|
|
Primary Sponsor
|
| Name |
Mysore medical college and research institute |
| Address |
Irwin road
Mysore
Karnataka 570001 |
| 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 |
| Dr Seenivasan V |
Krishna Rajendra Hospital |
Department of Anaesthesiology - Mysore medical college and research institute
1st floor , New Stone Building
KR Hospital , Irwin road
Mysore
Mysore
KARNATAKA |
9095763387
seenilav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore medical college and research institute and associated hospitals. Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H652||Chronic serous otitis media, (2) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
combination of lignocaine and diltiazem |
Administration of study drug lignocaine 1.5ml/kg body weight and diltiazem 0.1ml/kg body weight for second group of patients 2 minutes before extubation undergoing elective surgeries under general anaesthesia to assess the hemodynamic response of endotracheal extubation |
| Intervention |
Lignocaine |
Administration of study drug lignocaine 1.5ml/kg body weight for one group of patients 2 minutes before extubation undergoing elective surgeries under general anaesthesia to assess the hemodynamic response of endotracheal extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 patients
Patients with modified mallampati scores 1 and 2
Patients posted for elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with difficult airway
Patients with coexisting cardiovascular diseases
Patients with heart rate less than 60 beats per minute
Patients with blood pressure less than 100/60 mmhg
Patients with documented hepatic or renal diseases
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the hemodynamic responses to endotracheal extubation by monitoring heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the smoothness of extubation |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2024 |
| 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)
|
Not Applicable |
| 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
|
A comparative study to assess the stress response of the patient to endotracheal extubation using two different types of drugs |