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 -

May 22, 2013 updated by: Yonsei University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kwan-woong Choi
  • Phone Number: (82) 2-2227-4613
  • Email: sanctum@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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