Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202722
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2005-09-12
Brief Title:
Remifentanil as Intravenous Patient-controlled Analgesia IVPCA During Labour
Sponsor:
Sorlandet Hospital HF
Organization:
Sorlandet Hospital HF
Study Overview
Official Title:
Remifentanil as Analgesia for Labour Pain
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Remifentanil is a ultra short-acting synthetic opioid It is rapidly metabolized by non-specific blood and tissue esterases We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour Intravenous patient controlled analgesia ivpca were used to administer remifentanil Doses used were 015-105 mikrogrkg with a lock-out time of 2 minutes 41 women were included in the study Blood-pressure heartrate SaO2 respiration rate and sedation were recorded every 15minute Fetal heart rate was recorded for the whole periode of treatment CTG STAN Vaginal contraction pain were assessed by the parturients every 15minute using a Visual Analogue Scale VAS Midwives also recorded their impression of the parturients pain The parturients level of sedation were recorded by anesthesiologist and midwife every 15minute Apgar scores were registered at 1 5 and 10 min after delivery Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed After delivery both mother and midwife evaluated efficacy and safety Global satisfaction score if the remifentanil doses were sufficient nausea vomiting level of sedation and dizziness
Detailed Description:
Primary and secondary outcome measures presented under results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None