Comparison of Analgesic Efficacy and Occurrence of Emesis... | NCT01863355

Studies
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 -

NCT01863355

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

May 27, 2013Estimated

Enrollment

225Estimated

Phase

Not Applicable

Conditions

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

Interventions

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

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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 -

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

May 22, 2013

First Submission Date that Met QC Criteria

May 22, 2013

First Posted Date

May 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2013

Last Update Posted Date

May 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B0	Experimental	(basal rate 0cc/hr, bolus 3cc, lockout time 10min)	Drug: B0 group: bolus 0.6mcg/kg without background infusion
BL	Active Comparator	(basal rate 1cc/hr, bolus 2cc, lockout time 10min)	Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr
BH	Active Comparator	(basal rate 2cc/hr, bolus 1cc, lockout time 10min)	Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B0 group: bolus 0.6mcg/kg without background infusion	Drug		B0	Fentanyl based intraveonus patient controlled analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score(VAS) within 48hrs after surgery	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kwan-woong Choi	Contact	(82) 2-2227-4613		sanctum@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Yonsei University Health System	Recruiting	Seoul		120-752	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms