Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -

Study Overview
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Brief Summary
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Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background infusion rate) for effective pain control with minimal side effects such as nausea and vomiting

Conditions
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The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy

Intervention / Treatment
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* Drug: B0 group: bolus 0.6mcg/kg without background infusion
* Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr
* Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 70 ASA class I and II Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy Exclusion Criteria: Cardiovascular disease(uncontrolled hypertension, unstable angina, congestive heart failure, etc.) Renal failure Liver failure Chronic drug or alcohol abuser Anti-cancer chemotherapy Chronic opioid use Use of antiemetics within 24hrs for nausea and vomiting

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B0<br>(basal rate 0cc/hr, bolus 3cc, lockout time 10min) | Drug: B0 group: bolus 0.6mcg/kg without background infusion<br> <br> * Other names: Fentanyl based intraveonus patient controlled analgesia;|
| Active Comparator: BL<br>(basal rate 1cc/hr, bolus 2cc, lockout time 10min) | Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr<br> <br> * Other names: Fentanyl based intraveonus patient controlled analgesia;|
| Active Comparator: BH<br>(basal rate 2cc/hr, bolus 1cc, lockout time 10min) | Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr<br> <br> * Other names: Fentanyl based intraveonus patient controlled analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score(VAS) within 48hrs after surgery | Pain score after surgery within 48hrs after laparoscopic gastrectomy | Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy