- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245581
Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes
September 18, 2014 updated by: Yuan-Yi Chia, Kaohsiung Veterans General Hospital.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 81362
- Kaohsiung Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients are undergoing elective spine laminectomy
Exclusion Criteria:
- age <20 yr
- emergency surgery
- coagulopathy
- renal and hepatic dysfunction
- hyperthyroidism, and cardiac rhythm other than sinus rhythm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SVV-guided fluid management
SVV : Stoke volume variation
|
|
|
Active Comparator: CVP-guided fluid management
CVP : Central venous pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain at rest and movement
Time Frame: Post-operation Day1 to Day4
|
Post-operation Day1 to Day4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
September 10, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Estimate)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- VGHKS-102-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.