Closed-loop Sedation of Propofol for Patients Undergoing... | NCT01020643

Studies
Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

NCT01020643

Sponsor

Thomas Hemmerling

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

203Actual

Phase

Phase 4

Conditions

Conscious Sedation

Interventions

controlled administration of propofol

Countries

Canada

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

Oct 2013

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

Nov 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

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

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Hemmerling, MSc, MD, DEAA,, McGill University Health Centre/Research Institute of the McGill University Health CentreSponsor-Investigator

Lead Sponsor

Thomas HemmerlingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
controlled sedation using propofol	Experimental		Drug: controlled administration of propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
controlled administration of propofol	Drug	comparison of propofol sedation	controlled sedation using propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Controller performance		1 year

Secondary Outcomes

Measure	Description	Time Frame
fluid management	fluid management manual versus guided	end of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria:

contraindication to spinal anesthesia
allergies to any study drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Hemmerling, MD	MUHC - MGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUHC - Montreal General Hospital		Montreal	Quebec	H3G 1A4	Canada