| CTRI Number |
CTRI/2024/04/065025 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| 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
|
Effectiveness of two different doses (2.5mg and 5mg) of oral ivabradine to decrease the blood pressure and heart rate response due to intubation |
|
Scientific Title of Study
|
Efficacy of two different doses of oral ivabradine for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation-a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mulagapaka Raghuram Naidu |
| Designation |
post graduate trainee |
| Affiliation |
kalinga institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Kalinga institute of medical sciences,KIIT deemed to be university,Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
6303964677 |
| Fax |
|
| Email |
raghuramnaidum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pardha Sarathi Mohapatra |
| Designation |
Associate Professor |
| Affiliation |
kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology,Kalinga institute of medical sciences,KIIT Deemed to be university, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7205566361 |
| Fax |
|
| Email |
partha.mohapatra@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Sarathi Mohapatra |
| Designation |
Associate Professor |
| Affiliation |
kalinga institute of medical sciences |
| Address |
Department of Anaesthesiology,Kalinga institute of medical sciences,KIIT deemed to be university, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7205566361 |
| Fax |
|
| Email |
partha.mohapatra@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Mulagapaka Raghuram Naidu |
| Address |
Department of Anaesthesiology,KIIT Deemed to be university,PIN:751024 |
| Type of Sponsor |
Other [self] |
|
|
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 Partha Sarathi Mohapatra |
Pradyumna Bal Memorial hospital Kalinga institute of medical sciences |
Department of Anaesthesia Kalinga institute of medical sciences , Bhubaneswar 751024
Khordha
ORISSA |
7205566361
partha.mohapatra@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE KALINGA INSTITUTE OF MEDICAL SCIENCES |
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 |
| Intervention |
Ivabradine |
Group I oral ivabradine (2.5mg per oral )one hour before intubation and monitor intubation response for 10 minutes post intubation
|
| Comparator Agent |
Ivabradine |
Group II: oral ivabradine (5mg per oral) one hour before intubation and monitor intubation response for 10 minutes post intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients posted for elective surgeries under
general anaesthesia
2)Mallampati grade 1 and 2 patients
3)American Society of Anaesthesiologists (ASA)I,II |
|
| ExclusionCriteria |
| Details |
1.Heart rate less than 60 beats per min and SBP less than 100 mmhg
2.Sick sinus syndrome, Ecg abnormalities, visual disturbances.
3.Calcium channel blockers, azoles, antifungals, antiretroviral drugs and macrolides
4.pregnancy and lactating females
5.Difficult Intubation and laryngoscopy more than 15 seconds |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To measure heart rate 1 minute after intubation. |
1minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To measure heart rate 3min, 5min, 8min and 10 min after intubation.
2)To measure SBP, DBP, MAP after 1min, 3min,5min,8min,10min after intubation.
3)Incidence of bradycardia, visual disturbances
|
24hrs |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
.Ivabradine is a very unique cardiotonic drug, it reduces the heart rate without hemodynamic changes .Ivabradine inhibits the funny current (“If†channels) in sinoatrial nodal tissue that leads to decrease in the rate of diastolic depolarisation and consequently decreases heart rate without affecting blood pressure .previous studies have shown at this doses (2.5mg and 5mg)of oral ivabradine decreases response to laryngoscopy and endotracheal intubation .we assume that oral ivabradine at lower doses can attenuate the hemodynamic response to laryngoscopy and endotracheal intubation Primary objective: To estimate the efficacy of two different doses (2.5mg and 5 mg) of oral ivabradine for attenuation of hemodynamic response during laryngoscopy and intubationSecondary objective: To estimate incidence of side effects of ivabradine: bradycardia, visual disturbances like luminous phenomenon. |