The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted GastrectomyNCT01863355
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 -
A study testing B0 group: bolus 0.6mcg/kg without background infusion, BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr and BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr in people with The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
- What is being tested?
- B0 group: bolus 0.6mcg/kg without background infusion, BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr and BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70
- ASA class I and II
- Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Kwan-woong Choi, (82) 2-2227-4613, sanctum@yuhs.ac
About this study
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
- Conditions
- The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
- Being tested
- 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
- Keywords
- IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B0 group: bolus 0.6mcg/kg without background infusionDrug
Also called Fentanyl based intraveonus patient controlled analgesia
BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hrDrug
Also called Fentanyl based intraveonus patient controlled analgesia
BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hrDrug
Also called Fentanyl based intraveonus patient controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| B0 | Experimental | (basal rate 0cc/hr, bolus 3cc, lockout time 10min) Receives: Drug: B0 group: bolus 0.6mcg/kg without background infusion |
| BL | Active comparator | (basal rate 1cc/hr, bolus 2cc, lockout time 10min) Receives: 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) Receives: Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score(VAS) within 48hrs after surgery
Pain score after surgery within 48hrs after laparoscopic gastrectomy
Measured: Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted GastrectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863355
- Sponsor's protocol ID
- 4-2013-0176
- Status last verified
- May 2013
- First submitted
- 22 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 -
- ClinicalTrials.gov ID
- NCT01863355
- Acronym / sponsor ID
- 4-2013-0176
- Conditions
- The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
- Keywords
- IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B0 | Experimental | Drug: B0 group: bolus 0.6mcg/kg without background infusion(basal rate 0cc/hr, bolus 3cc, lockout time 10min) |
| BL | Active comparator | Drug: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr(basal rate 1cc/hr, bolus 2cc, lockout time 10min) |
| BH | Active comparator | Drug: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr(basal rate 2cc/hr, bolus 1cc, lockout time 10min) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 70
- ASA class I and II
- Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy
Key exclusion criteria (7 listed)
- Cardiovascular disease(uncontrolled hypertension, unstable angina, congestive heart failure, etc.)
- Renal failure
- Liver failure
- Chronic drug or alcohol abuser
- Anti-cancer chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B0 group: bolus 0.6mcg/kg without background infusionAlso: Fentanyl based intraveonus patient controlled analgesia | Drug | B0 |
| BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hrAlso: Fentanyl based intraveonus patient controlled analgesia | Drug | BL |
| BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hrAlso: Fentanyl based intraveonus patient controlled analgesia | Drug | BH |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B0 group: bolus 0.6mcg/kg without background infusion, BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr and BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr in people with The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwan-woong Choi ((82) 2-2227-4613, sanctum@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.