Efficacy and Satisfaction With Remifentanil Analgesia in... | NCT02447757

Studies
Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth

NCT02447757

Sponsor

Brno University Hospital

Status

Completed

Last Update Posted

Jul 26, 2016Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Complication of Labor and/or Delivery

Interventions

remifentanil

Countries

Czechia

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

Jul 2016

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

Jan 2010

Primary Completion Date

Jan 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

May 15, 2015

First Submission Date that Met QC Criteria

May 15, 2015

First Posted Date

May 19, 2015Estimated

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

Jul 22, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Name	Class
Hospital Sokolov	UNKNOWN

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

Retrospective observational study to determine the efficacy of remifentanil during the delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia induction) and parturients satisfaction with the method.

Detailed Description

In retrospective observational study will authors search the documentation of parturients. The cohort size is estimated to 100 subjects, in period between 2010-2014. Excluded will be all patients who did not signed the informed consent for processing with their medical data.The main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery.

The analgesic efficacy will be evaluated by the change in VAS (visual analogue scale) score after induction of remifentanil analgesia Satisfaction will be evaluated by the questionary.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parturients with remifentanil analgesia		Parturients after induction of remifentanyl analgesia during the delivery	Drug: remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
remifentanil	Drug	Remifentanil analgesia during delivery	Parturients with remifentanil analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of remifentanyl analgesia during the delivery	To evaluate the efficacy of remifentanil analgesia during the first phase of delivery in parturients by observing changes in VAS score	VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of delivery

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction with analgetic method	Patients will fill the questionaire to obtain their opinion on the remifentanil analgesia	Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

parturients during the delivery
administered remifentanil analgesia
signed informed consent

Exclusion Criteria:

informed consent not signed
missing data about the analgetic method a analgetic efficacy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Parturients during the delivery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KDAR - department of pediatrics anesthesia and resuscitation		Brno	Brno	62500	Czechia
Sokolov Hospital

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided