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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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B0

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

Group Type EXPERIMENTAL

B0 group: bolus 0.6mcg/kg without background infusion

Intervention Type DRUG

BL

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

BH

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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B0 group: bolus 0.6mcg/kg without background infusion

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Fentanyl based intraveonus patient controlled analgesia Fentanyl based intraveonus patient controlled analgesia Fentanyl based intraveonus patient controlled analgesia

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No