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Differences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor

Differences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor - maternal temperature and oxygen saturation during delivery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32311
Enrollment
175
Registered
2008-05-28
Start date
2008-12-12
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor pain

Interventions

Remifentanil group: 40microgram boluses, lockout time 2 min. Maximum dose limit is 1200 microgram/hour. Epidural group: ropivacaine plus sufentanil. Loading dose 25 mg (12.5 ml ropivacaine 0.2%), fo

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age *18 years * Between 37-42 weeks of gestation * Singleton pregnancy * ASA physical status I or II

Exclusion criteria

Exclusion criteria: * Prior administration of regional of opioid analgesia (during this delivery). * Morbid obesity (BMI * 40 kg/m2) * Drug allergy: history of hypersensitivity to opioid or local anesthetic substances * High risk pregnancy: including severe asthma (daily use of medication), insulin dependent diabetes, severe pre-eclampsia (proteinuria * 5 grams) * Use of antibiotics during delivery * Initial maternal SpO2 of less than 98% * Initial maternal temperature of 38°C or higher. * Cervical dilation of > 7 cm * Ruptured membranes for more than 24 hours at time of inclusion * Contraindication for epidural analgesia

Design outcomes

Primary

MeasureTime frame
* Maternal temperature * Maternal saturation

Secondary

MeasureTime frame
* To compare the incidences of other known side effects, in particular nausea, pruritus, sedation and hypotension. * Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)