NCT02245581

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 10, 2014

Last Update Submit

September 18, 2014

Conditions

Patients Major Laminectomy Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain at rest and movement

    Post-operation Day1 to Day4

Study Arms (2)

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

SVV-guided fluid managementPROCEDURE
SVV-guided fluid management
CVP-guided fluid managementPROCEDURE
CVP-guided fluid management

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients are undergoing elective spine laminectomy

You may not qualify if:

  • age \<20 yr
  • emergency surgery
  • coagulopathy
  • renal and hepatic dysfunction
  • hyperthyroidism, and cardiac rhythm other than sinus rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesia doctor

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 19, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

TW(1)