| CTRI Number |
CTRI/2024/12/078154 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between oral Ivabradine and Intravenous Esmolol for their efficacy in achieving pressor response during intubation, in ASA grade I patients |
|
Scientific Title of Study
|
Attenuation of pressor response to laryngoscopy and endotracheal intubation with oral Ivabradine versus intravenous Esmolol in American society of Anesthesiologist physical status grade I patients - Open label randomised control 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 |
sundharalingam senthilraj |
| Designation |
postgraduate |
| Affiliation |
government medical college, nalgonda. |
| Address |
Department of pharmacology,
Government medical college. Nalgonda. Department of pharmacology Nalgonda TELANGANA -508001 India |
| Phone |
8012177178 |
| Fax |
|
| Email |
lingas2984@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tadvi Naser Ashraf |
| Designation |
Head of the department and Professor |
| Affiliation |
government medical college, nalgonda. |
| Address |
Department of pharmacology Government medical college,
Nalgonda.
Nalgonda TELANGANA -508001 India |
| Phone |
9052734381 |
| Fax |
|
| Email |
nasertadvi@yahoo.co.uk |
|
Details of Contact Person Public Query
|
| Name |
sundharalingam senthilraj |
| Designation |
postgraduate |
| Affiliation |
government medical college, nalgonda. |
| Address |
Department of Pharmacology
Government medical college,
Nalgonda - 508001
Nalgonda TELANGANA -508001 India |
| Phone |
8012177178 |
| Fax |
|
| Email |
lingas2984@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college |
| Address |
Near RTC Bus Stand, Gollaguda, Nalgonda - 508001 |
| 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 |
| sundharalingam senthilraj |
Government medical college and hospital |
Department of Pharmacology Nalgonda TELANGANA |
8012177178
lingas2984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical college ethic committee GMC. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H948||Other specified disorders of ear in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ESMOLOL |
Intravenous esmolol is administered 1mg/kg 2 minutes before induction. Esmolol is a short acting beta-blocker that rapidly reduces the heart rate and is used in acute settings where rapid heart rate control is necessary |
| Intervention |
IVABRADINE |
Ivabradine is administered orally at a dosage of 5mg, 2 hours before endotracheal intubation.It selectively inhibits the If current in the sinoatrial node, reducing heart rate without affecting myocardial contractility or intracardiac conduction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a.American Society of Anesthesiologists (ASA) –Physical Status grade I
b.Patients with Mallampatti class I and II
c.Patients with Normal ECG
d.Patients Scheduled for elective non- cardiac surgery requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
a.Patients refusal or not consented to participate in the study.
b.Patient with previous H/O Chest Pain/ Palpitations/Syncope
c.Patient with H/o Respiratory Problems
d.Patient with Hepatic or renal Problems
e.Patient with Known allergies to Esmolol or Ivabradine
f. Patient with History of cardiac conduction abnormalities.
g.Patient with ECG abnormalities
h.Patient with difficult airway
i.Patient with Heart rate less than 60/minute and Systolic blood pressure less than 100mmHg
j.Patient with total duration of laryngoscopy and intubation more than 20 seconds
k.Patient with Mallampatti class III and IV
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Heart rate,
Mean Systolic blood pressure
Mean diastolic blood pressure |
At base level, after study drug, after induction, after intubation, 1st minute, 3rd minute, 5th minute, 8th minute, 10th minute, 1st hour and 2nd hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction |
after 12 hours of study drug |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2025 |
| 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 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
|
Airway management is a critical skill for anesthesiologists, particularly during laryngoscopy and endotracheal intubation, which often trigger a cardiovascular stress response. This response, characterized by transient hypertension, tachycardia, and elevated serum catecholamines, can result in serious cardiovascular complications, especially in high-risk patients. Effective management of this pressor response is therefore essential to ensure patient safety and optimize outcomes during surgery. Esmolol, a cardio-selective beta-blocker with a short half-life, has been widely studied for its ability to attenuate the pressor response and maintain hemodynamic stability. Conversely, Ivabradine, a selective inhibitor of the "If" current in the sinoatrial node, offers a unique mechanism of reducing heart rate without affecting myocardial contractility or blood pressure. Unlike beta-blockers, Ivabradine is suitable for use in patients with contraindications to beta-blockers, such as those with bronchial asthma, diabetes, or normotensive conditions. While studies have established the individual efficacy of Esmolol and Ivabradine in blunting the cardiovascular stress response to intubation, no direct comparative study has been conducted to evaluate their relative effectiveness. This randomized controlled trial aims to bridge this gap by comparing oral Ivabradine and intravenous Esmolol in attenuating hemodynamic responses to laryngoscopy and intubation in ASA Grade I patients undergoing elective surgeries. The findings will provide evidence-based insights into optimal pharmacological interventions to minimize perioperative cardiovascular risks and refine anesthetic protocols. RELEVANCE OF RESEARCH PROPOSAL TO PUBLIC HEALTH: 1. Understanding the comparative effectiveness of pharmacological interventions will directly contributes to enhancing patient safety during endotracheal intubation. 2. Identifying the most effective agent for blunting the pressor response ensures the delivery of high-quality care to patients, reduce the risk of cardiovascular complications associated with this procedure. 3. Anesthetic protocols play a pivotal role in ensuring positive perioperative outcomes. This research has the potential to influence and optimize anesthesia protocols. 4. By providing evidence-based insights into the comparative efficacy of esmolol and Ivabradine, the study will contribute to refining anesthesia practices, promoting standardization, and improving the overall quality of care.
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