Use of a single dose oral ivabradine as an adjuvant agent to the conventional general anaesthetic technique for perioperative haemodynamic stabilization.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Compare tachycardia and hypertension incidence in both groups.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Adaptive randomization, such as minimization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient belonging to ASA, Grade-I status, posted for elective non-cardiac abdominal laprscopic surgeries of 2-4 hour estimated duration.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Compare tachycardia and hypertension incidence in both groups.
Time Frame: 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 Outcomes
- A) To find out incidence of following in both groups(Bradycardia (≤60 beats/minutes))
- B) To find out any other adverse effect of the drug ivabradine.(From one hour after taking drug till 24 hours)