COMPARISON OF ORAL TAPENTADOL AND ORAL PREGABALIN- TWO ANALGESIC DRUGS FOR PAIN RELIEF IN HEART SURGERIES

Phase 3

• Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

• Registration Number: CTRI/2021/11/037858
• Lead Sponsor: Dr RIYA SHAH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients posted for elective cardiac surgery using midline sternotomy incision under general anaesthesia

2.Both males and females

3.Age group between 18-65 years,

4.Patients weighing between 40 kg â?? 85 kg

Exclusion Criteria

1.Patients with persistent nausea or vomiting at the time of randomization

2.Patients on mono amino oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors

3.Patients with Epilepsy, traumatic brain injury, stroke, transient ischemic attack, or brain tumor

4.Patients with opioid tolerance or opioid dependence

5.Patients having renal disease (creatinine >1.4 mg/dL)

6.Patients having liver disease (total bilirubin >1.5 mg/dL)

7.Patients having known allergies to any of the study drug

8.Patients having major psychiatric disorder

9.Pregnancy

10.Patients with left ventricular dysfunction (ejection fraction < 40%), patients on preoperative vasoactive drugs orintraaortic balloon pump (IABP)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare following parameters in both the groups <br/ ><br>1)Duration of analgesia <br/ ><br>2)Haemodynamic parameters (heart rate & mean arterial pressure) <br/ ><br>3)Adverse effect such as headache and nausea, vomiting <br/ ><br>4)Sedation score. <br/ ><br>Timepoint: Post operatively 0,3,6,12,24 hourly

Secondary Outcome Measures

Name	Time	Method
To compare following parameters in both the groups <br/ ><br>1) Total consumption of analgesic agents in the post operative period <br/ ><br>2) Intra operative analgesic (Fentanyl) requirement <br/ ><br> <br/ ><br>Timepoint: 1 year