| CTRI Number |
CTRI/2022/04/042188 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
26/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect Of Oral Ivabradine In Suppression of Stress Response To Laryngoscopy And Intubation |
|
Scientific Title of Study
|
Effect Of Oral Ivabradine In Attenuating The Hemodynamic Stress Response To Laryngoscopy And Endotracheal Intubation- A Multicentric Prospective Study |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
GCS Medical college Hospital and Research Centre Opposite DRM Office Chamunda Bridge Naroda Ahmedabad
Department of Anaesthesia GCS Medical college Hospital and Research Centre Opposite DRM Office Chamunda Bridge Naroda Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9712981484 |
| Fax |
07966048000 |
| Email |
drankitapatel30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
B/39 C P Nagar part 1 Bhuyangdev Cross Road Ghatlodiya Ahmedabad
Department of Anaesthesia GCS Medical college Hospital and Research Centre Opposite DRM Office Chamunda Bridge Naroda Ahmedabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
9712981484 |
| Fax |
07966048000 |
| Email |
drankitapatel30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
B/39 C P Nagar part 1 Bhuyangdev Cross Road Ghatlodiya Ahmedabad
Department of Anaesthesia GCS Medical college Hospital and Research Centre Opposite DRM Office Chamunda Bridge Naroda Ahmedabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
9712981484 |
| Fax |
07966048000 |
| Email |
drankitapatel30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GCS Medical college Hospital and Research centre |
| Address |
Department of Anaesthesia GCS Medical college Hospital and Research Centre Opposite DRM Office Chamunda Bridge Naroda Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Patel |
GCS Medical College and Hospital |
Department Anesthesia GCS medical college hospital research centre Ahmedabad
Ahmadabad
GUJARAT |
9712981484
07966048000
drankitapatel30@gmail.com |
| Dr N Pratheeba |
Indira Gandhi Medical College |
Department Anesthesia indira ghandhi medical college and research institute
Pondicherry
PONDICHERRY |
9894919554
pratheeba.rk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institute Ethics Committee |
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 |
not applicable |
not applicable |
| Intervention |
Oral Ivabradine |
5mg ivabradine to be given intra oral one hour before the procedure |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 50 yrs.
ASA 1 & 2
BMI < 30 kg/m2
MPG Grade 1&2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Low HR<60/min, SBP<100
ASA GRADE 3 & 4
BMI>30 kg/m2
Pregnancy and lactation
MPG Grade 3&4
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral Ivabradine is effective during laryngoscopy and intubation |
Immediately after intubation and 1min 3min 5min 8min and 10 min after intubation and during extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ivabradine reduced the stress responces during laryngoscopy and during intubation |
In 3 Months duration |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/05/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effect of Oral Ivabradine in attenuating the
hemodynamic stress response to laryngoscopy and Endotracheal intubation: A Multicentric research study AIM:To study the effect of oral ivabradine in attenuating
hemodynamic stress response to laryngoscopy and endotrachial intubation and extubation.
Primary objective: To study the hemodyamics ( HR, SBP,DBP and
MAP) at time of laryngoscopy and endotrachial intubation and extubation.
Secondary objective: To study the
incidence of side effects ( bradycardia, hypotension) and complication . •Randomized double
blind study •Total = 100 (Adult
pts undergoing surgery
under general anesthesia)
•Two groups
Group A – Tablet Ivabradine
Group B – placebo (sugar coated tablet)
•We are monitoring
mean HR, SBP, DBP, MAP spo2, etco2 At
baseline, At time of induction/ intubation( 1 ,3, 5, 8 ,10 min after
intubation) and At time of extubation (1,3,5,8,10 min
after extubation). Conclusion: We Conclude that Ivabradine is an extremely useful drug and can be used to prevent tachycardia during larygoscopy and intubation.
|