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 -

Yonsei University

Status: Unknown

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

Treatments: Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr; Drug: B0 group: bolus 0.6mcg/kg without background infusion; Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr

Study type: Interventional

Funder types: Other

Identifiers

NCT01863355

4-2013-0176

Details and patient eligibility

About

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

Enrollment: 225 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

B0

Experimental group

Description:

(basal rate 0cc/hr, bolus 3cc, lockout time 10min)

Treatment:

Drug: B0 group: bolus 0.6mcg/kg without background infusion

BL

Active Comparator group

Description:

(basal rate 1cc/hr, bolus 2cc, lockout time 10min)

Treatment:

Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr

BH

Active Comparator group

Description:

(basal rate 2cc/hr, bolus 1cc, lockout time 10min)

Treatment:

Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr