Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-12 @ 8:01 AM
Study NCT ID:
NCT02122705
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case Series of VPIA Using Remifentanil for Labour and Delivery
Sponsor:
KK Women's and Children's Hospital
Organization:
Study Overview
Official Title:
A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
Status:
COMPLETED
Status Verified Date:
2015-09
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:
VPIA
Brief Summary:
This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.
Detailed Description:
This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.
The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.
The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.
Study Oversight
Has Oversight DMC:
True
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?: