CTRI/2018/05/013902.
Trial name or title | A study of central and mixed venous oxygen saturation with outcomes in open heart surgery patients between two groups conventional general anaesthesia and combined with perioperative thoracic epidural or intravenous analgesia |
Methods | Randomized (computer generated; open list of random numbers; participant, investigator and outcome assessor blinded) |
Participants | 80 adults with coronary artery disease aged from 40 to 70 years Inclusion criteria: requiring off‐pump open heart bypass surgery Exclusion criteria: abnormal coagulation profiles, requiring salvage coronary artery bypass grafting, cardiogenic shock, heart valve pathology, antiplatelet therapy continuing local infection; renal, metabolic, neurological, or psychiatric disorders |
Interventions | Intervention: epidural analgesia (10 mL bupivacaine 025%) Comparator: intravenous analgesia |
Outcomes | 1. Central venous and mixed venous oxygen saturation during intraoperative period and time for extubation and length of postoperative intensive care unit stay 2. Stress response, inotropic/vasodilatory support, pain outcome, and analgesia requirements 3. New arrhythmia, postoperative blood loss, perioperative myocardial infarction, neurological events, infective complication, if present 4. Any other adverse effects during the study period |
Starting date | Started: 26 March 2013 Completed: 25 November 2013 Trial registered retrospectively: 5 May 2018 Unpublished results |
Contact information | Dr. Chaitali Sen Professor and Head Institute of Post Graduate Medical Education & Research, Kolkata Department of Cardiac Anesthesiology IPGMER and SSKM Hospital, 242 A J C Bose Road Kolkata, West Bengal, 700020, India Email: chaitali03@rediffmail.com |
Notes | Found on 6 February 2019 |