Clinical Trial: VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Co
Brief Summary: This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia
Detailed Summary:
This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates 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 pump and step down doses accordingly when predefined critical values are reached.
Sponsor: KK Women's and Children's Hospital
Current Primary Outcome: Maternal desaturation [ Time Frame: Duration of labour ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Maternal bradycardia [ Time Frame: Duration of labour, an expected average of 24 hours ]
- Apnoea/hypopnoea [ Time Frame: Duration of labour, an expected average of 24 hours ]
Original Secondary Outcome: Same as current
Information By: KK Women's and Children's Hospital
Dates:
Date Received: December 30, 2015
Date Started: December 2016
Date Completion: March 2018
Last Updated: February 5, 2017
Last Verified: January 2017
