To study the effectiveness of Pregabalin given before surgery on pain , heart rate , and blood pressure stability in patients undergoing cardiac surgery
Phase 3
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 2: I059- Rheumatic mitral valve disease, unspecified
- Registration Number
- CTRI/2019/12/022487
- Lead Sponsor
- VMMC and Safdarjung Hospital New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient undergoing CABG, single valve replacement on Cardiopulmonary bypass machine.
Exclusion Criteria
-Left ventricular Ejection Fraction (LVEF) less than 50%
-Co-morbidities like severe respiratory disorder, obstructive sleep apnea, hepatic insufficiency, renal disease, cerebrovascular disease.
-Preoperative cardiomyopathies, left bundle branch block, left main artery blockage, preoperative intra-aortic balloon pulsation (IABP) or temporary pacing .
-History of prolonged opioid use, gabapentin, pregabalin before surgery.
-Difficult airway Mallampati grade III & IV
-Body mass Index (BMI) >=30
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study and compare the analgesic efficacy of oral Pregabalin on patients undergoing cardiac surgery in the perioperative period. <br/ ><br>2.To study the hemodynamic response to intubation and sternotomy <br/ ><br>3.To compare two doses of Pregabalin on perioperative pain. <br/ ><br>Timepoint: Baseline <br/ ><br>1 min of intubation <br/ ><br>5 min of intubation <br/ ><br>10 min of intubation <br/ ><br>1 min after sternotomy <br/ ><br>5 min after sternotomy <br/ ><br>10 min after sternotomy
- Secondary Outcome Measures
Name Time Method 1.To study the duration of mechanical ventilation post-surgery. <br/ ><br>2.To study the incidence of sedation post-surgery. <br/ ><br>3.To see the incidence of complications like nausea, vomiting or any other complication <br/ ><br>4.To study the duration till meeting criteria to shift to room <br/ ><br>Timepoint: Post Extubation <br/ ><br>2 HRS <br/ ><br>4 HRS <br/ ><br>24 HRS <br/ ><br>SHIFTING FROM IC