Comparing Two Types of Sedation to Gynaecological Patients | NCT01412632

Studies
Comparing Two Types of Sedation to Gynaecological Patients

NCT01412632

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

153Actual

Phase

Phase 4

Conditions

Transcervical Resection of Endometrium
Transcervical Resection of Fibroids
Transcervical Resection of Polyp

Interventions

Remifentanil, propofol and citanest

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 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 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Aug 8, 2011

First Posted Date

Aug 9, 2011Estimated

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 30, 2014

Last Update Posted Date

Oct 1, 2014Estimated

Name	Class
Regionshospitalet Horsens	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Detailed Description

Investigate the difference between two types of anesthesia.

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

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General vs deep sedation	Experimental	General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest	Drug: Remifentanil, propofol and citanest

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remifentanil, propofol and citanest	Drug	iv remifentanil iv propofol im citanest	General vs deep sedation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain on a NRS-scale from 0 to 10	Measuring postoperative pain in TCRE, TCRF or TCRP patients	up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
PONV		postoperative and 2 weeks after discharge
Time	Operating time Recovery time Discharge time	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years
females
are having a TCRE, TCRF or TCRP
speak and understand Danish
no mental problems

Exclusion Criteria:

<18 years old
don´t speak or understand Danish
mental problems
Lung problems
BMI >40
Big fibroma: >3x3 cm
abuser
Allergy towards i Propofol, Remifentanil and/or Citanest
pregnant

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Name	Affiliation	Role
Igor Filipovski	Regionshospital Horsens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regionshospitalet Horsens		Horsens	Region Midt	8700	Denmark

Type	Date	Date Unknown
Release	Feb 29, 2016
Reset	Mar 29, 2016
Release	Aug 8, 2016
Reset	Sep 29, 2016
Release	Oct 3, 2016
Reset	Nov 25, 2016

Submission Tracking

Estimated Results First Submitted Date

Feb 29, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 29, 2016			Mar 29, 2016
Aug 8, 2016

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil
D015742	Propofol
D011318	Prilocaine

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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Browse Branches

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