Gastric Cancer Patients Undergoing Laparoscopic GastrectomyPhase 4NCT02164448
The Effects of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
A Phase 4 study testing the dexmedetomidine group in people with Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
- What is being tested?
- the dexmedetomidine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 4
- 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
- patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
- gastric cancer patient undergoing laparoscopic gastrectomy
Who cannot join
- ASA physical status Ⅳ
- bradycardia (< 60 bpm), arrhythmia
- uncompensated heart failure
- hepatic failure (Child-Pugh score B 이상)
- renal failure (eGFR MDRD < 60 ml/min/1.73m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
Seoul, Seoul, 120-752
About this study
The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of intraoperative dexmedetomidine infusion on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.
- Being tested
- the dexmedetomidine group, the control group
- Keywords
- dexmedetomidine, postoperative bowel movement, laparoscopic gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the dexmedetomidine groupDrug
the dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery
the control groupDrug
saline infusion from induction of anesthesia to end of surgery
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Experimental | Not described Receives: Drug: the dexmedetomidine group |
| control group | Placebo comparator | Not described Receives: Drug: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
gas passing
To evaluate the postoperative bowel movement, we will assess the time to first gas passing
Measured: up to 1 week
Secondary outcomes (1)
sips of water time
To evaluate the postoperative bowel movement, we will assess the time to resume water intake
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Patients Undergoing Laparoscopic 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164448
- Sponsor's protocol ID
- 4-2014-0249
- Status last verified
- May 2015
- First submitted
- 9 Jun 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02164448
- Acronym / sponsor ID
- 4-2014-0249
- Keywords
- dexmedetomidine, postoperative bowel movement, laparoscopic gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jun 2014 (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.
The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of intraoperative dexmedetomidine infusion on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Experimental | Drug: the dexmedetomidine group |
| control group | Placebo comparator | Drug: the control group |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
- gastric cancer patient undergoing laparoscopic gastrectomy
Key exclusion criteria (5 listed)
- ASA physical status Ⅳ
- bradycardia (< 60 bpm), arrhythmia
- uncompensated heart failure
- hepatic failure (Child-Pugh score B 이상)
- renal failure (eGFR MDRD < 60 ml/min/1.73m2)
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 |
|---|---|---|
| the dexmedetomidine groupthe dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery | Drug | dexmedetomidine group |
| the control groupsaline infusion from induction of anesthesia to end of surgery | Drug | control group |
Primary outcome
gas passing
Time frame: up to 1 week
To evaluate the postoperative bowel movement, we will assess the time to first gas passing
1 secondary outcome
sips of water time
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing the dexmedetomidine group in people with Gastric Cancer Patients Undergoing Laparoscopic 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gas passing (time frame: up to 1 week). 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 2015.