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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Experimental | Remifentanil Patient Controlled Analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Vital signs-controlled, patient assisted intravenous analgesia using remifentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal desaturation | Duration of labour |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal bradycardia | Duration of labour, an expected average of 24 hours | |
| Apnoea/hypopnoea | Duration of labour, an expected average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects: pruritus | Pruritus | Duration of labour, an expected average of 24 hours |
| Side effects: nausea vomiting | Nausea/vomiting | Duration of labour, an expected average of 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan Ling Leong, MBBS FANZCA | Contact | +6563941081 | leong.wan.ling@singhealth.com.sg | |
| Ban Leong Sng, MBBS FANZCA | Contact | +6563941081 | sng.ban.leong@singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Wan Ling Leong, MBBS FANZCA | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Recruiting | Singapore | Singapore | 229899 | Singapore |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Side effects: sedation | Sedation | Duration of labour, an expected average of 24 hours |
| Maternal outcomes: duration of labour | Duration of labour (minutes) | Duration of labour, an expected average of 24 hours |
| Maternal outcomes: duration of second stage | Duration of second stage (minutes) | At delivery, an expected average of 1 hour |
| Maternal outcomes: pain score | Maternal pain score (out of 10) | Duration of labour, an expected average of 24 hours |
| Maternal outcomes: satisfaction score | Maternal satisfaction score (%) | Duration of labour, an expected average of 24 hours |
| Neonatal outcomes: birth weight | Birth weight in grams | Immediately after birth |
| Neonatal outcomes: APGAR | APGAR scores | Immediately after birth |
| Neonatal outcomes: cord blood pH | Umbilical cord blood pH | Immediately after birth |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |