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CTRI Number  CTRI/2017/11/010505 [Registered on: 15/11/2017] Trial Registered Prospectively
Last Modified On: 15/11/2017
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   Role of medicine named ivabradine in tablet form to control changes in blood pressure and heart rate of patients undergoing surgery except heart surgery.  
Scientific Title of Study   Use of a single dose oral ivabradine as an adjuvant agent to the conventional general anaesthetic technique for perioperative haemodynamic stabilization. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anwesha Banerjee 
Designation  PG Student, Anaesthesia 
Affiliation  Institute of Medical Science and SUM Hospital 
Address  Department of Anaesthesia, Pain Palliative & Critical Care Institute of Medical Sciences and SUM Hospital, Siksha-O-Anusandhan (SOA) University, Kalinga Nagar, Bhubaneswar.

Khordha
ORISSA
751003
India 
Phone  7750870025  
Fax    
Email  anwesha2801@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anwesha Banerjee 
Designation  PG Student, Anaesthesia 
Affiliation  Institute of Medical Science and SUM Hospital 
Address  Department of Anaesthesia, Pain Palliative & Critical Care Institute of Medical Sciences and SUM Hospital, SOA University, Kalinga Nagar, Bhubaneswar.

Khordha
ORISSA
751003
India 
Phone  7750870025  
Fax    
Email  anwesha2801@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanghamitra Mishra 
Designation  Professor 
Affiliation   
Address  Department ofAnaesthesia, Pain Palliative & Critical Care Institute of Medical Sciences and SUM Hospital, Kalinga Nagar, Bhubaneswar.

Khordha
ORISSA
751003
India 
Phone  9438002233  
Fax    
Email  sanghamitramishra@soauniversity.ac.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Pain, Palliative Care and Critical Care, Institute of Medical Sciences and SUM Hospital, Kalinga Nagar, Bhubaneswar, Orrisa 
 
Primary Sponsor  
Name  Dr Anwesha Banerjee 
Address  Institute of Medical Sciences and SUM Hospital, Siksha-O-Anusandhan University, Kalinga Nagar, Bhubaneswar, Orrisa 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof Sanghamitra Mishra  epartment of Anaesthesia, Pain, Palliative and Critical Care, IMS and SUM Hospital, Kalinga Nagar, Bhubaneswar, Odisha 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anwesha Banarjee  Operation Theatre No. 1, Modular Surgery Operation Theatre Complex, First Floor  Department of Anaesthesia, Pain, Palliative & Critical Care, Institute of Medical Sciences and SUM Hospital, Siksha-O-Anusandhan University, Kalinga Nagar, Bhubaneswar
Khordha
ORISSA 		 7750870025

anwesha2801@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American Society of Anaesthesiology, GRADE-I, Healthy patients, undergoing surgery.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1: group I (Ivabradine group) Intervention with oral ivabradine.  Group 1 The patients will be given tablet ivabradine 7.5mg orally 2 hours before surgery. Patients will undergo surgery under conventional general anaesthesia technique with routine monitoring. 
Intervention  Group2: group C (Control group) Conventional non- intervention group  The patient will undergo surgery under conventional general anaesthesia technique with routine monitoring. Unlike the previous group no additional interventional drug is used. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient belonging to ASA, Grade-I status, posted for elective non-cardiac abdominal laprscopic surgeries of 2-4 hour estimated duration. 
 
ExclusionCriteria 
Details  1) Patients with history of any medication or substance abuse
2) Age< 18 year or >50 year
3) Weight < 40 kg or > 70 kg
4) Height <150cm or >170cm
5) Baseline heart rate <60bpm or ≥90 bpm
6) Baseline Blood Pressure
≤ 90/50/65 mm Hg or ≥140/85/105 mm Hg
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Compare tachycardia and hypertension incidence in both groups.  i) Just before laryngoscopy.
ii) Immediately after intubation.
iii) Every minute after intubation till 5 minutes.
iv) At time of surgical incision.
v) Every minute till 5 minutes of incision.
vi) At time of recovery from anaesthesia.
vii) Every one minute till 5 minutes of extubation.
viii) Ten minutes after extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
A) To find out incidence of following in both groups
Bradycardia (≤60 beats/minutes)
Absolute Bradycardia (≤60 beats/minutes)
Tachycardia (≥90 beats/minutes)
Hypotension (≤90/50/65 mmHg)
Hypertension (≥140/85/105 mmHg)
 		 Every ten minutes intraoperatively starting from 15 minutes before intubation till 10 minutes after extubation. 
B) To find out any other adverse effect of the drug ivabradine.  From one hour after taking drug till 24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/01/2018 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Gordon F. Rushworth et al. Ivabradine: a new rate-limiting therapy for coronary artery disease and heart failure 2011 Ther Adv Drug Saf. Feb; 2(1): 19–28. 2. Ragueneau I et al. . (1997)Pharmacokinetic–pharmacodynamic modelling of the effects of ivabradine, a direct sinus node inhibitor, on heart rate in healthy volunteers. Clin Pharmacol Therapeut 64: 192–203 3. Camm A.J., Lau C. (2003) Electrophysiological effects of a single intravenous administration of ivabradine (S 16257) in adult patients with normal baseline electrophysiology. Drugs R&D 4: 83–89 4. Gopalan Nair Rajesh et al. A comparative study of ivabradine and atenolol in patients with moderate mitral stenosis in sinus rhythm. Indian Heart J. 2016 May-Jun; 68(3): 311–315.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Perioperative hemodynamic fluctuations are of serious consequences  during cardiac surgeries and also associated with increased morbidity and mortality  during non cardiac surgeries. Currently perioperative administration of beta blockers and alpha-2 agonist are the established therapeutic options for the same.

 

   Beta blockers like Metoprolol, though effective for haemodynamic stabilization, because of its combined negative ionotropic & chronotropic action may raise the possibility of obtunding compensatory physiological mechanisms at the time of need during perioperative period.

 

 Regarding Dexmedetomidine, there are few reports of excessive sedation along with excessive bradycardia associated with hypotension. Also it is a costly medication.

 

   Till recently ivabradine has been used extensively in cases of cardiac failure, myocardial ischemia, and cardiomyopathies for its funny channel associated dependable heart rate reducing property. But its perioperative role in haemodynamic stabilization in comparision to established drugs like betablockers have not been evaluated perioperatively during non cardiac surgery.

 

    Ivabradine is the first If current inhibitor to be clinically useful at reducing heart rate and is absorbed quickly and almost completely via the oral route. Peak plasma concentrations are seen after 2 hour if taken with food.

 

Ivabradine, the hyperpolarization-activated pacemaker current (IF) channel inhibitor which induces heart rate reduction by selective sinus node. It  specifically inhibits the pacemaker current (funny current, If) of the sinoatrial node cells, resulting in therapeutic heart rate lowering without any negative inotropic and blood pressure-lowering effect.

 
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