| CTRI Number |
CTRI/2026/03/105831 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Comparative Study of the Efficacy of Oral Ivabradine and Oral Gabapentin in Attenuating Haemodynamic Response to Laryngoscopy and Endotracheal Intubation |
|
Scientific Title of Study
|
A Comparative Study Of The Efficacy Of Oral Ivabradine And Oral Gabapentin In Attenuating Haemodynamic Response To Laryngoscopy And Endotracheal Intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhilesh Mukerji |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767981911 |
| Fax |
|
| Email |
akhileshmukerji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Bhushan Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Department of Anaesthesiology, Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Dr. D.Y.Patil Medical College, Hospital and Research Centre
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
bhavini.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Bhushan Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Department of Anaesthesiology, Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Dr. D.Y.Patil Medical College, Hospital and Research Centre
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
bhavini.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
AKHILESH MUKERJI |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College Hospital and Research Centre, Pimpri, Pune, Maharashtra, India, 411018
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune |
| 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 Akhilesh Mukerji |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
8800147678
akhileshmukerji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I977||Intraoperative cardiac functionaldisturbances, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GABAPENTIN |
TAB. GABAPENTIN 800MG 1 hour prior to induction of surgery |
| Intervention |
IVABRADINE |
TAB. IVABRADINE 5MG 1 hour prior to induction of surgery |
| Comparator Agent |
PLACEBO |
TAB. VITAMIN C GIVEN 1 hour prior to induction of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Patients aged between 18 years and 60 years of age belonging to either sex
3. Patients undergoing surgeries under general anaesthesia requiring intubation.
4. Haemodynamically stable patients with all routine investigations within normal limits and
without any comorbidities.
5. Written informed consent from the concerned patient. |
|
| ExclusionCriteria |
| Details |
1. Patients who have history of allergy to the drug being used for the study.
2. Patients who are not willing to participate in the study.
3. Patients will HR less than 60 and Heart Block conditions.
4. Patients on medications that affect the heart rate or blood pressure, pregnant patients.
5. Patients with ASA grade III and above physical status.
6. Patients who are aged less than 18 years and more than 60 years of age.
7. Patients who are posted for emergency procedures.
8. Patients who have psychiatric, neurological, cardiovascular disease, difficult airway or
impairment of hepatic or renal function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effects of oral Ivabradine and Gabapentin on haemodynamic response such
as Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) during laryngoscopy and intubation. |
Baseline (before administration of study drug),
preoperatively,
0 minute (intubation)
1 minute after intubation,
3rd minute after intubation,
5th minute after intubation,
8th minute after intubation,
10th minute after intubation,
30 minutes,
60 minutes
90 minutes
120 minutes
2 hours post operatively,
6 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine which drug more effectively attenuates the haemodynamic response |
Baseline (before administration of study drug),
preoperatively,
at induction,
at intubation,
1 minute after intubation,
3rd minute after intubation,
5th minute after intubation,
8th minute after intubation,
10th minute after intubation,
30 minutes,
60 minutes
90 minutes
120 minutes
2 hours post operatively,
6 hours post operatively |
| To evaluate the incidence of adverse events & sedation related to the study drug. |
Baseline (before administration of study drug),
preoperatively,
at induction,
at intubation,
1 minute after intubation,
3rd minute after intubation,
5th minute after intubation,
8th minute after intubation,
10th minute after intubation,
30 minutes,
60 minutes
90 minutes
120 minutes
2 hours post operatively,
6 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/03/2026 |
| 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
|
It is a prospective, randomized, comparative study to assess the attenuation of hemodynamic response to pre operative administration of Oral Ivabradine and Oral Gabapentin for patients undergoing surgeries under General Anaesthesia. Hemodynamic parameters such as SBP, DBP, MAP and HR will be recorded throughout the perioperative period and the efficacy of the mentioned drugs will be assessed.
Efficacy of the drugs will be compared and adverse effect profile will be assessed perioperatively. |