Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
NCT Number: NCT04434430
This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Jakarta, DKI Jakarta, 10430, Indonesia
Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Gabapentin 600 mg
Oral NaCl 500 mg
Time frame: 24 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Time frame: 24 hours after surgery
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Time frame: 2 hours after surgery
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Time frame: 6 hours after surgery
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Time frame: 12 hours after surgery
Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.
The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
Time frame: 2 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Time frame: 6 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Time frame: 12 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
Indonesia University
Other
Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery
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