Patients Major Laminectomy SurgeryNCT02245581
Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes
A study testing SVV-guided fluid management and CVP-guided fluid management in people with Patients Major Laminectomy Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Major Laminectomy Surgery
- What is being tested?
- SVV-guided fluid management and CVP-guided fluid management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients are undergoing elective spine laminectomy
Who cannot join
- age <20 yr
- emergency surgery
- coagulopathy
- renal and hepatic dysfunction
- hyperthyroidism, and cardiac rhythm other than sinus rhythm
Trial locations and contacts
1 site in 1 country.
About this study
Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using Chi-Square test. P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. Statistical analysis will be carried out using standardize statistical programs SPSS 12.0 for windows.
- Conditions
- Patients Major Laminectomy Surgery
- Being tested
- SVV-guided fluid management, CVP-guided fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVV-guided fluid managementProcedure or surgery
CVP-guided fluid managementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SVV-guided fluid management | Active comparator | SVV : Stoke volume variation Receives: Procedure: SVV-guided fluid management |
| CVP-guided fluid management | Active comparator | CVP : Central venous pressure Receives: Procedure: CVP-guided fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest and movement
Measured: Post-operation Day1 to Day4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Major Laminectomy SurgeryStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Yi Chia, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245581
- Sponsor's protocol ID
- VGHKS-102-036
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes
- ClinicalTrials.gov ID
- NCT02245581
- Acronym / sponsor ID
- VGHKS-102-036
- Conditions
- Patients Major Laminectomy Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 19 Sep 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.
Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using Chi-Square test. P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. Statistical analysis will be carried out using standardize statistical programs SPSS 12.0 for windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVV-guided fluid management | Active comparator | Procedure: SVV-guided fluid managementSVV : Stoke volume variation |
| CVP-guided fluid management | Active comparator | Procedure: CVP-guided fluid managementCVP : Central venous pressure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients are undergoing elective spine laminectomy
Key exclusion criteria (5 listed)
- age <20 yr
- emergency surgery
- coagulopathy
- renal and hepatic dysfunction
- hyperthyroidism, and cardiac rhythm other than sinus rhythm
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 |
|---|---|---|
| SVV-guided fluid management | Procedure or surgery | SVV-guided fluid management |
| CVP-guided fluid management | Procedure or surgery | CVP-guided fluid management |
Primary outcome
Pain at rest and movement
Time frame: Post-operation Day1 to Day4
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 19 Sep 2014.
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 study testing SVV-guided fluid management and CVP-guided fluid management in people with Patients Major Laminectomy Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 1 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 19 Sep 2014. 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 Taiwan. 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?
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?
Pain at rest and movement (time frame: Post-operation Day1 to Day4). 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 19 Sep 2014.