Evaluations of Optimizing Perioperative Fluid Management... | NCT02245581

Studies
Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes

NCT02245581

Sponsor

Kaohsiung Veterans General Hospital.

Status

Completed

Last Update Posted

Sep 19, 2014Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Patients Major Laminectomy Surgery

Interventions

SVV-guided fluid management
CVP-guided fluid management

Countries

Taiwan

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Sep 10, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 19, 2014Estimated

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

Sep 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

Description Module

Brief 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. 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.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SVV-guided fluid management	Active Comparator	SVV : Stoke volume variation	Procedure: SVV-guided fluid management
CVP-guided fluid management	Active Comparator	CVP : Central venous pressure	Procedure: CVP-guided fluid management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SVV-guided fluid management	Procedure		SVV-guided fluid management
CVP-guided fluid management

Measure	Description	Time Frame
Pain at rest and movement		Post-operation Day1 to Day4

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Veterans General Hospital		Kaohsiung City		81362	Taiwan