Ketamine Effects as Preemptive Analgesia

Study Overview
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Brief Summary
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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: To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery

Official Title
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Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ketamine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-50 years. ASA I and II physical status (American Society of Anesthesiologists). Exclusion Criteria: The patient is not willing to be included as a research subject The patient takes anti-pain medication before surgery History of allergies to the drugs to be used History of chronic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preemptive Ketamine<br>Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision | Drug: Ketamine<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision | Other: Placebo<br>* While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Preemptive Analgesia