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Clinical trial

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

ID
Name
AN-202309.02
Description
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: 1. 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 2. 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
Trial arms
Trial start
2022-12-27
Estimated PCD
2023-03-03
Trial end
2023-03-03
Status
Completed
Phase
Early phase I
Treatment
Ketamine
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.
Arms:
Preemptive Ketamine
Placebo
While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe
Arms:
Placebo
Size
40
Primary endpoint
Duration of postoperative analgesia
24 hours post operative
Total need for post-operative analgesic rescue
24 hours post operative
Eligibility criteria
Inclusion Criteria: 1. Patients aged 18-50 years. 2. ASA I and II physical status (American Society of Anesthesiologists). Exclusion Criteria: 1. The patient is not willing to be included as a research subject 2. The patient takes anti-pain medication before surgery 3. History of allergies to the drugs to be used 4. History of chronic pain
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-09-22

1 organization

1 drug

2 indications

Organization
Universitas Padjadjaran
Drug
Ketamine
Indication
Pain
Indication
Postoperative