TCI vs Manually Controlled Infusion of Propofol | NCT04266535

Studies
TCI vs Manually Controlled Infusion of Propofol

NCT04266535

Sponsor

Regional Hospital West Jutland

Status

Unknown status

Last Update Posted

Feb 17, 2020Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Anesthesia, Intravenous
Laparotomy
Airway Extubation

Interventions

Target controlled infusion

Countries

Not provided

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Oct 1, 2020Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 12, 2020Actual

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

Feb 12, 2020

Last Update Posted Date

Feb 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Niels Peter Ekeløf, Principal Investigator, Regional Hospital West JutlandPrincipal Investigator

Lead Sponsor

Regional Hospital West JutlandOTHER

Collaborators

Not provided

Description Module

Brief Summary

Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.

The aim of the study is to verify differences in time to extubation and amount of drugs used.

anesthetize

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TCI		Patients receiving Target Controlled Infusion (TCI) Anesthesia	Device: Target controlled infusion
MCI		Patients receiving Manually Controlled Infusion (MCI) Anesthesia	Device: Target controlled infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Target controlled infusion	Device	Target controlled infusion vs manually controlled infusion	MCI TCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post procedural awakening	Time from the surgical procedure has ended until arrival at the post anesthesia unit (PACU)	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients to laparoscopic surgery

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Anestectic records

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided