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 -

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01863355

Enrollment

225

Registered

2013-05-27

Start date

2013-05-31

Completion date

2014-12-31

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy

Brief 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

Interventions

DRUGB0 group: bolus 0.6mcg/kg without background infusion

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

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

Countries

South Korea

Contacts

Primary ContactKwan-woong Choi

sanctum@yuhs.ac(82) 2-2227-4613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026