search
Back to results

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 -

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
B0 group: bolus 0.6mcg/kg without background infusion
BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr
BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy focused on measuring IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

B0

BL

BH

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pain score(VAS) within 48hrs after surgery
Pain score after surgery within 48hrs after laparoscopic gastrectomy

Secondary Outcome Measures

Full Information

First Posted
May 22, 2013
Last Updated
May 22, 2013
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT01863355
Brief Title
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
Keywords
IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B0
Arm Type
Experimental
Arm Description
(basal rate 0cc/hr, bolus 3cc, lockout time 10min)
Arm Title
BL
Arm Type
Active Comparator
Arm Description
(basal rate 1cc/hr, bolus 2cc, lockout time 10min)
Arm Title
BH
Arm Type
Active Comparator
Arm Description
(basal rate 2cc/hr, bolus 1cc, lockout time 10min)
Intervention Type
Drug
Intervention Name(s)
B0 group: bolus 0.6mcg/kg without background infusion
Other Intervention Name(s)
Fentanyl based intraveonus patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr
Other Intervention Name(s)
Fentanyl based intraveonus patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr
Other Intervention Name(s)
Fentanyl based intraveonus patient controlled analgesia
Primary Outcome Measure Information:
Title
Pain score(VAS) within 48hrs after surgery
Description
Pain score after surgery within 48hrs after laparoscopic gastrectomy
Time Frame
Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwan-woong Choi
Phone
(82) 2-2227-4613
Email
sanctum@yuhs.ac
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwan-woong Choi
Phone
(82) 2-2227-4613
Email
sanctum@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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 -

We'll reach out to this number within 24 hrs