Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth

July 22, 2016 updated by: Petr Štourač, MD, Brno University Hospital

Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth: Retrospective Observational Study

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brno, Czech Republic, 62500
        • KDAR - department of pediatrics anesthesia and resuscitation
      • Sokolov, Czech Republic, 356 01
        • Sokolov Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturients during the delivery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parturients with remifentanil analgesia
Parturients after induction of remifentanyl analgesia during the delivery
Remifentanil analgesia during delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of remifentanyl analgesia during the delivery
Time Frame: VAS score before the induction of remifentanyl infusion and 1hour after initiation of remifentanil analgesia during the first phase of 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with analgetic method
Time Frame: Before initiation of anagetic method (first phase of delivery) and 1hour after childbirth
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (ESTIMATE)

May 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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