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The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preemptive Ketamine | Active Comparator | Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision |
|
| Placebo | Placebo Comparator | Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative analgesia | Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA | 24 hours post operative |
| Total need for post-operative analgesic rescue | The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA | 24 hours post operative |
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Inclusion Criteria:
Exclusion Criteria:
Women only
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| Name | Affiliation | Role |
|---|---|---|
| Iwan Fuadi, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Study Director |
| Ardi Zulfariansyah, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Study Director |
| Jacklin E Mokoginta, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Padjadjaran | Bandung | West Java | 40161 | Indonesia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Other | While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |