KK Women's & Children's Hospital
Singapore
NCT Number: NCT02122705
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.
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Notify Me18 year–45 year
Female
Observational
Singapore
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vital signs controlled patient assisted intravenous analgesia using remifentanil
Time frame: Duration of labour
Hourly maternal pain scores
Time frame: Duration of labour
Total and hourly remifentanil drug consumption.
Time frame: Duration of labour and 1st day post delivery
Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting
Time frame: Duration of labour and one day post delivery
Mode of delivery Duration of second stage Overall satisfaction with labour analgesia
Time frame: Duration of labour and one day post delivery
Birth weight APGAR scores at 1 and 5 minutes umbilical cord blood pH
KK Women's and Children's Hospital
Other Gov
A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
Acronym: VPIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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