Value of Target-controlled Intravenous Anaesthesia (TCIVA... | NCT02821897

Studies
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation

NCT02821897

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Apr 8, 2019Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Failed Back Surgery Syndrome

Interventions

Target-controlled intravenous anaesthesia
Total anaesthesia

Countries

France

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

Apr 2019

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

Mar 2013

Primary Completion Date

Nov 17, 2017Actual

Completion Date

Nov 17, 2017Actual

First Submitted Date

Jun 27, 2016

First Submission Date that Met QC Criteria

Jul 1, 2016

First Posted Date

Jul 4, 2016Estimated

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

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

Description Module

Brief Summary

Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Target-controlled Intravenous Anaesthesia	Experimental	Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.	Procedure: Target-controlled intravenous anaesthesia
Total anesthesia	Active Comparator	Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.	Procedure: Total anaesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Target-controlled intravenous anaesthesia	Procedure		Target-controlled Intravenous Anaesthesia
Total anaesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping		6 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years and ≤ 80 years
FBSS
Radicular leg et lumbar pain
For more than 3 months after one or many spine surgeries
Mixt pain (radicular leg et lumbar) with Neuropathic status
Failure of conservative treatment
Severe uni or bilateral radicular pain > 5 / 10

Exclusion Criteria:

Age <18 years and> 80 years.
BMI > 30 kg/m2.
Back pain that can be treated by surgery (discogenic, vertebral instability, …)
Contraindication to TCIVA anesthesia under propofol remifentanil
Psychiatric status
Cancer
No signature of informed consent.
Women of childbearing without contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

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
CHU de Poitiers		Poitiers	Worldwide	86000	France

Condition Browse Module

MeSH Terms

ID	Term
D055111	Failed Back Surgery Syndrome

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain

Browse Leaves

Not provided

Browse Branches

Not provided