To study the effectiveness of Pregabalin given before surgery on pain , heart rate , and blood pressure stability in patients undergoing cardiac surgery

To study the efficacy of preoperative Pregabalin on perioperative pain and haemodynamic stability in patients undergoing cardiac surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022487

Enrollment

300

Registered

2019-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: I059- Rheumatic mitral valve disease, unspecified

Interventions

Intervention1: Group S: Pregabalin 75mg will be given orally one hour prior to surgery Intervention2: Group P: Pregabalin 150 mg will be given orally one hour prior to surgery Control Intervention1: G

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing CABG, single valve replacement on Cardiopulmonary bypass machine.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1.To study and compare the analgesic efficacy of oral Pregabalin on patients undergoing cardiac surgery in the perioperative period. 2.To study the hemodynamic response to intubation and sternotomy 3.To compare two doses of Pregabalin on perioperative pain. Timepoint: Baseline 1 min of intubation 5 min of intubation 10 min of intubation 1 min after sternotomy 5 min after sternotomy 10 min after sternotomy	—

Measure

Time frame

1.To study and compare the analgesic efficacy of oral Pregabalin on patients undergoing cardiac surgery in the perioperative period. 2.To study the hemodynamic response to intubation and sternotomy 3.To compare two doses of Pregabalin on perioperative pain. Timepoint: Baseline 1 min of intubation 5 min of intubation 10 min of intubation 1 min after sternotomy 5 min after sternotomy 10 min after sternotomy

—

Secondary

Measure	Time frame
1.To study the duration of mechanical ventilation post-surgery. 2.To study the incidence of sedation post-surgery. 3.To see the incidence of complications like nausea, vomiting or any other complication 4.To study the duration till meeting criteria to shift to room Timepoint: Post Extubation 2 HRS 4 HRS 24 HRS SHIFTING FROM ICU	—

Countries

India

Contacts

Public ContactDeepa Kerketta Khurana

V.M.M.C and Safdarjung Hospital , New Delhi.

drdeepa.khurana@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026