Health Condition 1: M150- Primary generalized (osteo)arthritis
Conditions
Interventions
Intervention1: 5 mg Olanzapine: Single oral dose of the Drug to be administered one hour before arthroplasty and outcomes analyzed at specific time points.
Control Intervention1: 75 mg Pregabalin: Sin
Sponsors
All India Institute of medical sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients undergoing arthroplasty surgery. 2. Patients willing to provide written informed consent. 3. Patients who can swallow the capsule. 4. Age group between 18-65 years.
Exclusion criteria
Exclusion criteria: 1. Subjects having history of nausea or vomiting within 24 hours before enrolment. 2. Subjects with elevated lab parameters such as serum creatinine level of more than 2.0 mg per decilitre, aspartate or alanine aminotransferase level greater than 3 times of normal upper limit, and absolute neutrophil count were less than 150. 3. Subjects on treatment with either pregabalin or another antipsychotic agent within 30 days of enrolment or planned to receive them during the study period. 4.History of hypersensitivity to olanzapine or pregabalin. 5.History of uncontrolled congestive heart failure, cardiac arrhythmia, or acute myocardial infarction events within the previous six months. 6. Subjects with a history of diabetes mellitus. 7. History of upper gastrointestinal tract obstruction. 8. History of QTcF more than 450ms or torsades de pointes. 9. Clinically significant cardiovascular disease defined as follows: a. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery. b. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on antiarrhythmic medication. c. New York Heart Association (NYHA) Class II or higher congestive heart failure. 10. Patients with metabolic disorders (such as hypercalcemia, hyperglycaemia or hyponatremia, uraemia causing nausea and vomiting. 11. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of study subjects who have post operative nausea and vomiting within a 24-hour postoperative period following arthroplasty surgery. (use of Visual Analogue Scale)Timepoint: 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs post operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first incidence of PONV. 2. Incidence of PONV at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours post-surgery. 3. Nausea VAS score at 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery. 4. Requirement of rescue medication(s) during 24 hours of postoperative period. 5. The VAS score for patient satisfaction regarding nausea. Timepoint: 2, 4, 6, 12, 24 hours post- surgery | — |
Countries
India
Contacts
Public ContactSneha Kimi
AIIMS bhubaneswar
Outcome results
None listed