Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Intervention1: Tramadol Infusion 0.1 % w/v: Akums Drugs & Pharmaceutical Ltd India
Infusion, intravenously.
After recovery from anesthesia, Initial intravenous loading dose of 100 mg tramadol bolus, f
Sponsors
Akums Drugs Pharmaceutical Ltd India
NEXUS CLINICAL RESEARCH INDIA LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy). 2 Hospital stay at least for 24 hours is needed. 3 Cooperative and understanding skills. 4 Agreement to informed consent form.
Exclusion criteria
Exclusion criteria: 1 Hypersensitivity to any of the drugs components or other drug from same class. 2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study 3 Patient with history of drug of abuse. 4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache. 5 Pregnant and lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine change in Visual Analog scale pain scoreTimepoint: at day 1 (48 hours), day 2 (72 hours) and at end of study from baseline, | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine change in Visual Analog scale pain scoreTimepoint: till 24 hours (average cumulative scores during 24 hours post dose) as compared to baseline score. | — |
Countries
India
Contacts
Public ContactDr Mangesh Khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed