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 -
Conditions
The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
Conditions: Keywords
IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: B0 group: bolus 0.6mcg/kg without background infusion Type: Drug
Name: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr Type: Drug
Name: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr Type: Drug
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Status: Recruiting
Contact: Kwan-woong Choi - (82) 2-2227-4613 - sanctum@yuhs.ac
Start Date
May 2013
Completion Date
December 2014
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page