Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth

Complication of Labor and/or Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447757
• Other study ID #: KDAR Sokolov
• Status: Completed
• Phase: N/A
• First received: May 15, 2015
• Last updated: July 22, 2016
• Start date: January 2010
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Complication of Labor and/or Delivery
• Obstetric Labor Complications

Intervention

Drug:
• remifentanil
Remifentanil analgesia during delivery

Locations

Country	Name	City	State
Czech Republic	KDAR - department of pediatrics anesthesia and resuscitation	Brno
Czech Republic	Sokolov Hospital	Sokolov

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Hospital Sokolov

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No